Getting your medical device cleared by the FDA is a high-stakes process. A single misstep can set you back months and cost a fortune. Choosing the wrong regulatory pathway or submitting incomplete documentation can lead to rejection, forcing you to start over. This is why smart companies turn to expert consulting for medical device companies. These specialists understand the nuances of FDA requirements, from premarket approval consulting to the fine print of your labeling. With dedicated medical device labeling consulting, they help you prepare a compelling case for your device, protecting your investment and accelerating your timeline to market.
Key Takeaways
- Get it right the first time with an expert guide: A consultant’s primary value is helping you choose the correct regulatory pathway and prepare a solid submission, which prevents the costly delays and rejections that come from common mistakes.
- Choose a partner who understands your specific product: Vet potential firms by asking for case studies on similar devices and inquiring about their experience with your target markets, whether domestic or global, to ensure they are the right fit.
- A successful partnership is a two-way street: Maximize your investment by preparing your documentation, defining clear goals, and working with your consultant to establish a strong Quality Management System (QMS) for lasting compliance.
What Does a Medical Device Consultant Actually Do?
Bringing a medical device to market is an exciting prospect, but the path to getting it approved can feel like a maze of complex rules and requirements. This is where medical device approval consulting comes in. Think of a consultant as an expert guide who has walked this path many times before. They provide specialized services to help you get your product through the design, development, and regulatory approval stages successfully.
The reality is that getting a device cleared or approved by government bodies like the FDA is a demanding process. It requires a deep understanding of regulations, significant time, and a lot of resources. For most companies, trying to handle this alone can lead to costly delays and mistakes. Partnering with a consultant isn’t just about outsourcing tasks; it’s a strategic move to ensure your product reaches the people who need it as efficiently and safely as possible.
What Can a Consultant Do for You?
So, what does a medical device consultant actually do for you? Their work is hands-on and covers the entire regulatory journey. They start by offering strategic advice tailored to your specific product, helping you map out the clearest path to approval from the very beginning. This includes preparing and submitting all the necessary FDA documents and reports, which can be incredibly detailed and technical.
Consultants also review your marketing materials and product labeling to make sure every claim you make is compliant with FDA rules. If your device requires clinical trials, they can help you write the plans and protocols needed to gather the right data. They even prepare your team for critical meetings with the FDA, ensuring you can answer questions confidently. J&JCC Group offers comprehensive compliance solutions that support you at every one of these crucial steps.
FDA Inspection Support and Response
An FDA inspection can be one of the most stressful events for a medical device company. A consultant helps you prepare for these inspections and provides support when the investigators arrive. They can conduct mock inspections to simulate the real thing, which helps identify and correct any compliance gaps before they become official findings. This preparation ensures your team is confident and your facility is ready. During the actual inspection, your consultant can be on-site to help manage the process, answer questions, and address any potential issues in real-time, making sure your product can successfully enter the U.S. market.
U.S. Agent Services for Foreign Companies
If your company is based outside the United States, you are required to have a U.S. Agent to market your medical device in the country. This isn’t just a formality; your U.S. Agent is your official point of contact for the FDA. They handle communications, respond to inquiries, and assist with scheduling inspections. Choosing the right partner for this role is critical. A good U.S. Agent does more than just forward mail; they act as your regulatory representative on the ground. At J&JCC Group, we offer U.S. Agent services that provide you with a reliable and knowledgeable presence, ensuring you meet all FDA requirements for foreign establishments.
Specialized Labeling Support
Your device’s labeling is more than just a sticker; it includes all packaging, instructions for use (IFU), and promotional materials. Every word and claim is scrutinized by the FDA, and a single non-compliant statement can lead to a warning letter or product recall. Consultants review your device labels and packaging to ensure every piece of information complies with strict FDA regulations. They check that your claims are supported by data, that all necessary warnings are present, and that the formatting meets all requirements, protecting you from easily avoidable compliance issues.
Reimbursement and Contract Manufacturing Strategy
Many companies outsource production to a contract manufacturer, but it’s important to remember that the brand owner is always responsible for the device’s quality. A consultant helps you create clear quality agreements to ensure all manufacturing processes follow established quality system regulations. They also assist with developing a reimbursement strategy, which is key to your device’s commercial success. Getting your device covered by insurance providers requires a specific approach, and an expert can help you build the case needed for favorable coverage decisions, ensuring your product is accessible to the patients who need it.
Training and Legal Support
Regulatory compliance is a continuous effort that requires a well-informed team. Consultants offer customized training on FDA regulations, such as the Quality System Regulation (QSR), to ensure your staff understands their roles in maintaining compliance. This builds a strong internal culture of quality. Additionally, consultants can provide expert advice for legal cases. Should a legal challenge arise, they can serve as an expert witness or help your legal team understand the technical details of FDA compliance, ensuring your company is well-prepared for any situation.
How Experts Help You Meet Regulatory Requirements
The biggest advantage of working with a consultant is their deep expertise in FDA regulations. These experts live and breathe the laws and guidance documents that govern medical devices. One of their most critical roles is helping you choose the right regulatory pathway for your product, whether it’s a 510(k), PMA, or De Novo request. This single decision has a massive impact on your timeline and budget, and an expert can help you make the right choice for both your short-term and long-term goals.
Think of your consultant as a translator and a strategist. They understand the nuances of the FDA’s expectations and can help you present your information in the clearest, most effective way. They anticipate potential hurdles and develop plans to address them before they become major problems, guiding you through the entire process with confidence and clarity.
The Essentials of Medical Device Labeling
Once you have a clear regulatory pathway, the next major hurdle is labeling. Getting your medical device labeling right is non-negotiable. It’s not just about following rules; it’s about ensuring your device can be used safely and effectively by healthcare professionals and patients. The FDA has very specific requirements for what must be included and how it should be presented. A small mistake here can lead to significant compliance issues, recalls, or warning letters. This is an area where attention to detail is everything, and having an expert eye on your materials can save you from costly errors down the line.
What the FDA Considers “Labeling”
Beyond the Sticker: A Broader Definition
When you hear the word “label,” you probably picture the sticker on the product itself. But the FDA’s definition is much broader, a crucial distinction that trips up many companies. The agency considers “labeling” to be all written, printed, or graphic materials that accompany your device. This comprehensive view includes the immediate packaging, instructions for use (IFU), software interface messages, product manuals, and even your promotional materials and website content. Essentially, if it’s a piece of information associated with your device, the FDA sees it as part of the labeling. This is why a holistic compliance strategy is so important, ensuring every claim is accurate and consistent with the device’s intended use.
Core FDA and FTC Regulations to Know
Understanding 21 CFR Part 801 and 21 CFR Part 820.120
The FDA’s core requirements for medical device labeling are primarily outlined in 21 CFR Part 801. This regulation covers general labeling provisions, including the content and format of the information you must provide, such as the manufacturer’s name and the device’s intended use. In addition, 21 CFR Part 820.120, which is part of the Quality System Regulation, is equally important. It dictates that manufacturers must establish and maintain strict procedures to control all labeling activities. This ensures every label is accurate and helps prevent mix-ups that could put patients at risk, making it a cornerstone of your quality management system.
Ensuring Fair and Honest Marketing with the FTC
Beyond the FDA, the Federal Trade Commission (FTC) has authority over advertising to ensure it is truthful and not deceptive. This means all of your marketing claims must be fair and substantiated. The FTC and FDA often work together to address non-compliance in the medical device space, so your marketing and regulatory teams must be perfectly in sync. Every piece of promotional material, from a brochure to a social media post, must be both compelling and compliant, avoiding any claims that could be interpreted as misleading by either agency. This alignment protects your company and builds trust with your customers.
What Must Appear on a Medical Device Label?
Required Information: From Manufacturer to UDI
To comply with regulations, your label must include several key details. This includes the device’s common name, its intended use, and adequate directions for use (IFU), along with any necessary indications, contraindications, or warnings. You must also clearly state the manufacturer’s name and contact information. Furthermore, labels need an expiration date if applicable, a lot or serial number for tracking, and a Unique Device Identifier (UDI). The UDI is a critical component that helps the FDA and manufacturers track devices throughout their entire lifecycle, from distribution to patient use, improving safety and surveillance.
Using Standardized Symbols (ISO 15223-1)
To save space and create a universal understanding across different languages, you can use standardized symbols on your labeling. The most widely recognized set of symbols comes from the ISO 15223-1 standard, which includes icons for “manufacturer,” “use-by date,” and “caution.” While these symbols are incredibly useful for creating clean and internationally friendly labels, you can’t just place them on the packaging and call it a day. The FDA requires that you include a glossary or explanation of what each symbol means within your packaging or IFU, ensuring all users can interpret them correctly and safely.
Special Considerations for Patient-Use Devices
If your device is intended for use by patients at home, without the direct supervision of a healthcare professional, the bar for clear labeling is even higher. You have to assume the user has no medical training, so the design and language of your labeling must be incredibly simple and intuitive to prevent misuse. For these devices, your labeling should be written in plain language, use large, legible fonts with good color contrast, and include pictures or diagrams to improve comprehension. Most importantly, all risks and warnings must be presented clearly and prominently. Getting this right is a complex task where expert guidance, like the services offered by J&JCC Group, can help you meet both regulatory requirements and the needs of your users.
Understanding FDA Pathways and Common Roadblocks
Getting your medical device to market requires a clear strategy for regulatory approval. The FDA has several distinct pathways, each designed for different types of devices based on their risk level and novelty. Choosing the right path is one of the most critical decisions you’ll make, as it directly impacts your timeline, budget, and the data you need to collect. Understanding these routes and the common challenges that can arise will help you prepare for a smoother journey.
510(k), PMA, or De Novo: Which Pathway Is Right for You?
The FDA offers three primary routes for medical device approval. The most common is the 510(k) pathway, which is for medium-risk devices like glucose monitors or endoscopes. This path requires you to demonstrate that your device is “substantially equivalent” to a legally marketed device already in the U.S., known as a predicate device. For high-risk, life-sustaining devices like pacemakers, you’ll need to go through Premarket Approval (PMA), the most rigorous and lengthy process. Finally, the De Novo pathway is for new, low-to-moderate risk devices that have no existing predicate. It provides a route for innovative products that don’t fit the other two categories, blending thoroughness with efficiency.
How to Avoid Common Delays in the Approval Process
Many submissions get delayed by avoidable issues. Frequent problems include incorrect device classification, incomplete documentation, or a weak risk analysis. Choosing the wrong regulatory pathway from the start can also lead to significant setbacks, costing you both time and money. The key to clearing these hurdles is meticulous preparation. Double-checking that your submission is complete and accurate is non-negotiable. A well-documented quality management system and a thorough understanding of the specific requirements for your device class can prevent many of the most common mistakes and keep your approval process on track.
Going Global? What to Know About International Regulations
Securing FDA approval is a huge milestone, but it only gets you access to the U.S. market. If you have global ambitions, you’ll need to plan for international regulations from the beginning. Each country or region, like the European Union or the United Kingdom, has its own distinct set of rules and submission processes. Managing these different requirements can be incredibly complex and time-consuming. That’s why many companies partner with experts who specialize in comprehensive compliance solutions. A consulting firm can help you develop a global regulatory strategy, ensuring your device meets the necessary standards for every market you plan to enter.
Adhering to International ISO Standards
When you’re thinking about selling your device beyond the U.S., you’ll quickly run into ISO standards. These are the global benchmarks for quality and safety, and for medical devices, the most important one to know is ISO 13485:2016. This standard is all about your Quality Management System (QMS). It provides a framework to ensure your devices and services consistently meet both customer needs and regulatory rules, no matter where you sell them. Adhering to this standard isn’t just about checking a box; it’s about building a foundation of quality that regulators around the world trust. This is often a core part of the work a regulatory consultant does—helping you build a QMS that stands up to international scrutiny and makes entering new markets a much smoother process.
Meeting European Union Medical Device Regulation (EU MDR) Rules
If Europe is on your roadmap, you need to be prepared for the European Union’s Medical Device Regulation (EU MDR). This is one of the most stringent regulatory frameworks in the world, with incredibly detailed rules for everything from device traceability and post-market surveillance to the specific symbols on your labels. Many companies find that if they design their processes to meet these tough EU standards, they are well-positioned to comply with regulations in other regions, too. Handling the EU MDR is a significant undertaking, and a consultant with experience in European regulations can be the difference between a successful launch and a costly rejection, helping you interpret and apply these complex requirements correctly from the start.
Marketing Your Medical Device Compliantly
Once you’ve successfully received FDA clearance or approval for your medical device, it’s time to celebrate—but the work isn’t over. Now, you have to market it, and the FDA’s oversight extends to every single claim you make. The agency has a very broad definition of “labeling,” which includes not just the physical label on the device but also your website, brochures, social media posts, and sales scripts. Every piece of marketing material must align perfectly with the information you submitted in your 510(k) or PMA. This means every claim about your device’s performance and intended use must be truthful, not misleading, and supported by solid data.
Failing to get this right can have serious consequences. In fact, errors in labeling and marketing are one of the leading reasons the FDA issues warnings to medical device companies. Clear and correct information is essential for ensuring the device is used safely and effectively by healthcare providers and patients. When marketing claims don’t match the approved uses, it can lead to patient harm, product recalls, and significant penalties. This is why having an expert review your marketing materials is so valuable. A consultant can help you verify that every claim is compliant before it ever reaches the public, protecting your company from costly regulatory actions.
The Critical Risk of “Off-Label” Promotion
One of the most significant marketing pitfalls for medical device companies is “off-label” promotion. This means advertising or encouraging the use of your device for a purpose that has not been cleared or approved by the FDA. For example, if your surgical tool was cleared for use on soft tissue, you cannot promote it for cutting bone, even if you believe it works well for that purpose. The temptation can be strong, especially if your sales team or physicians discover new applications for your device. However, promoting these unapproved uses is a serious violation that can lead to major legal and financial trouble.
The only compliant way to market a new use for your device is to go back to the FDA. You must submit a new application with clinical data that supports the safety and effectiveness of the new intended use. While this requires additional time and investment, it is the only path forward. Sticking strictly to your FDA-approved claims is non-negotiable. It not only keeps your company compliant but also upholds your reputation and, most importantly, protects the health and safety of the patients who rely on your technology. Your marketing should build trust, and that starts with being transparent about what your device is proven to do.
Is Medical Device Consulting Worth the Cost?
Let’s talk about the numbers. Hiring a medical device approval consultant is a significant investment, so it’s smart to understand the costs. But this isn’t just an expense—it’s a strategic move to protect your product’s future. The right expert helps you avoid costly missteps and shorten your time to market. A failed submission or regulatory delay can cost far more than the upfront fee for getting it right the first time. When you consider the potential for lost revenue and rework, the value of expert guidance becomes crystal clear.
Breaking Down the Cost of Consulting Services
When you start looking for a consultant, you’ll find that pricing structures can vary. Most FDA consultants charge by the hour, with rates typically ranging from $150 to $500. Where a firm falls on that spectrum depends on their specific expertise and the complexity of your device. For instance, consultants with deep experience, like former FDA employees, often charge more for their valuable insider knowledge. Some firms may also offer project-based fees for a defined scope of work, like a 510(k) submission, or a monthly retainer for ongoing support. Always ask for a detailed proposal that outlines the expected costs and deliverables.
What Factors Influence the Cost?
The primary driver of your consulting cost is your project’s complexity. A simple Class I device requires less work than a novel Class III device needing a full Premarket Approval (PMA) application. The final price is also influenced by how prepared your team is. Consultants often spend significant time fixing common submission mistakes, such as incorrect device classification, incomplete documentation, or a weak risk analysis. Planning for international sales also adds complexity and cost. The more organized your internal documentation is, the more efficiently your consultant can work, saving you money in the long run.
Looking Ahead: The Long-Term Value of a Consultant
The real return on your investment comes from getting to market faster and more predictably. An experienced consultant’s most critical role is helping you select the most efficient regulatory pathway for your device, a decision that directly impacts your timeline and study costs. Getting it wrong can set you back months or even years. A consultant helps you avoid the high cost of a rejected submission by ensuring your application is complete and compelling from the start. This proactive approach saves you from rework, extra testing fees, and lost sales, delivering a return that makes the initial fee a smart business decision.
How to Choose the Right Medical Device Consultant
Choosing a consulting partner is one of the most important decisions you’ll make on your path to market. This isn’t just about hiring a service; it’s about finding a team that will integrate with yours, understand your vision, and guide you through a high-stakes process. The right partner can be the difference between a smooth, successful submission and a series of costly delays. Here’s what to look for and what to ask to find the perfect fit for your company.
What to Look For in a Medical Device Consultant
A great consultant does more than just fill out paperwork. They act as your strategic guide. First, look for deep expertise in regulatory requirements. Your ideal partner should have a team with a strong background in FDA regulations, possibly including former FDA staff. They need to know the rules inside and out. Second, check their track record. Ask for case studies or references that show a history of successful submissions, especially for devices similar to yours. Finally, consider the breadth of their services. A firm that can support you from initial strategy and quality management system development all the way through post-market surveillance offers a seamless, integrated experience, saving you time and preventing things from falling through the cracks.
Essential Qualifications and Experience
When you’re vetting a consultant, it’s time to dig past the sales pitch and into their specific qualifications. The most critical factor is their deep expertise in FDA regulations, paired with a proven track record with devices similar to yours. Ask them directly: Have you successfully guided products through the 510(k), PMA, or De Novo pathway? A great consultant acts as both a strategist and a translator, understanding the nuances of FDA expectations and helping you present your information effectively. They should be ready to provide case studies or references that prove their success. Remember, you’re not just hiring someone who knows the rules; you’re looking for a partner who has already cleared the path you’re about to walk.
Key Questions to Ask Before You Hire
Once you have a shortlist, it’s time to start asking tough questions. Don’t be shy—their answers will reveal a lot about how they operate. Start with their direct experience: “Have you successfully guided a product like ours through the 510(k) or PMA process?” Next, think about your long-term goals. If you plan to sell outside the US, ask, “What is your experience with global medical device regulations, particularly in the EU and UK?” Finally, get a feel for the working relationship. Ask, “What does your communication and collaboration process look like? Who will be my main point of contact?” The right partner will give you clear, confident answers that align with your company’s needs and culture.
Reputable Medical Device Consulting Firms to Consider
Finding the right firm can feel overwhelming, so I’ve put together a list of respected consultants in the medical device space to help you start your search. Each has a unique focus, so consider which one best aligns with your specific needs.
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J&JCC Group As specialists in regulatory compliance, we provide tailored consulting solutions to help you handle the complex medical device landscape. We work closely with our clients to create clear, effective strategies for FDA submissions and ongoing compliance.
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Emergo by UL With a strong focus on international markets, Emergo by UL helps medical device manufacturers manage the complexities of global market entry. They are a solid choice if you have your sights set on selling in multiple countries.
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MCRA MCRA is known for guiding companies through the entire FDA submission process, from the earliest strategic planning stages to final market approval. They have a strong track record with complex submissions, including PMAs.
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Greenlight Guru While also offering consulting, Greenlight Guru is widely recognized for its quality management software (QMS) built specifically for medical device companies. Their platform helps streamline documentation and compliance.
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Regulatory Compliance Associates Regulatory Compliance Associates offers a wide range of consulting services to help life science companies achieve and maintain regulatory compliance. They provide hands-on support across the entire product lifecycle.
How to Get the Most Out of Your Consultant
Hiring a consultant is the first step, but building a successful partnership is what truly gets your medical device to market. Think of it as a collaboration, not just a transaction. Your active involvement and clear communication are just as important as your consultant’s expertise. When you work together effectively, you can move through the complex approval process more efficiently and set your product up for long-term success.
To get the most out of your investment, focus on three key areas: preparing your team for the collaboration, looking beyond the initial FDA approval, and establishing a solid quality system from the start. These efforts will create a smoother process and a stronger foundation for your business.
Laying the Groundwork for a Great Partnership
To hit the ground running, you need to do a little prep work. Before your first major meeting, gather all your existing documentation—product designs, test data, business plans, and any previous regulatory correspondence. The more organized you are, the faster your consultant can get up to speed. It’s also essential to define your goals clearly. Do you need to get through a 510(k) submission by a specific quarter? Are you aiming for both FDA and international approval? Being upfront about your objectives and internal timelines helps your consultant build the right strategy for you. A great partnership is built on transparency, so be ready to share the good, the bad, and the ugly.
Beyond Approval: Long-Term Consulting Support
Getting that FDA clearance or approval is a huge milestone, but the work doesn’t stop there. Your consulting partner’s expertise is invaluable for strategic planning long after your product launches. They can provide comprehensive support throughout the entire product lifecycle, from initial concept to post-market surveillance. Lean on them for guidance on marketing claims to ensure they are compliant, or for help with handling any post-market issues that arise. This ongoing relationship helps you stay compliant as regulations evolve and allows you to plan for future product iterations or expansions into new markets with confidence.
Building a Solid quality management system
A robust quality management system (QMS) is the backbone of any successful medical device company. It’s not just a binder of documents to satisfy an auditor; it’s the operational framework that ensures your product is safe, effective, and consistently meets regulatory requirements. Your consultant can help you establish a quality management system that is tailored to your company’s size and complexity. This system is essential for maintaining product quality and is a prerequisite for compliance with both FDA regulations and international standards. Building a strong QMS from the beginning saves you from major headaches and potential compliance disasters down the road.
Labeling Controls Within Your QMS (GMPs)
Your QMS needs to cover every label that goes on your device, its packaging, and any accompanying literature. Under FDA regulations, specifically 21 CFR 820.120, you are required to establish and maintain strict procedures to control your labeling activities. This isn’t just about proofreading; it’s about creating a system. You need to ensure that labels remain legible and firmly attached during all stages of processing, storage, handling, and distribution. Think about the journey your product takes—will the ink fade in a hot warehouse? Will the adhesive fail in a humid climate? These are the kinds of practical details your labeling controls must address to ensure the right information gets to the end-user, every single time.
Documenting Label Checks in the Device History Record (DHR)
Before any label is applied to a device, it must be meticulously examined to confirm it is correct. This includes verifying critical information like the Unique Device Identifier (UDI), expiration dates, and control numbers. But the check itself isn’t enough; you have to prove you did it. This proof lives in the Device History Record (DHR), which is the complete production history for each batch, lot, or unit. Think of the DHR as the official logbook for your device. The FDA’s unofficial motto is, “If it wasn’t documented, it didn’t happen.” Recording these label checks in the Device History Record is non-negotiable and serves as objective evidence that you are following your own quality procedures.
Why the Brand Owner Is Ultimately Responsible
Many companies choose to outsource production to a contract manufacturer, but it’s crucial to understand that you cannot outsource regulatory responsibility. If your name is on the box, the FDA holds you—the brand owner—fully accountable for the device’s safety, quality, and compliance. You can’t simply trust that your manufacturing partner is doing everything right. You must verify it. This is why having a robust quality agreement in place is so critical. This legal document clearly defines the quality and regulatory responsibilities of each party. A consulting partner can be invaluable here, helping you establish a quality system and draft an agreement that protects your brand and ensures your partner meets all FDA requirements.
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Frequently Asked Questions
When is the right time to hire a medical device consultant? Ideally, you should bring a consultant on board as early as possible, even during the initial design and development phase. Many costly mistakes, like choosing the wrong materials or an inefficient regulatory path, happen long before you’re ready to submit anything to the FDA. An expert can provide strategic input from the start, ensuring you’re building your device and your documentation with regulatory success in mind, which saves you from expensive rework later on.
My device seems simple. Do I really need a consultant? It’s a fair question. While your device may be low-risk, the regulatory process itself is rarely simple. Even Class I devices have specific requirements for registration, labeling, and quality management that are easy to overlook. A consultant ensures that every box is checked correctly, preventing unexpected compliance issues that could delay your launch or lead to problems after you’re on the market. Think of it as insurance for a smooth and correct market entry.
What can our team do to help manage consulting costs? The best way to make your consulting partnership efficient is to be prepared. Before you even start, gather and organize all your existing documentation, from design specifications to any test data you’ve collected. Having a clear internal point person who can make decisions and communicate effectively with your consultant also saves a tremendous amount of time. The more organized and decisive you are, the less time your consultant has to spend on administrative tasks and the more they can focus on high-value strategic work.
What is the most common mistake companies make before seeking help? The most frequent and costly mistake is incorrectly classifying their device and choosing the wrong regulatory pathway. This single decision dictates your entire timeline, budget, and data collection requirements. Companies often underestimate the nuances and either pursue a path that’s too lenient, leading to rejection, or one that’s far too burdensome, wasting years and millions of dollars. Getting this right from the beginning is a consultant’s primary value.
Once my device is approved, is the work with a consultant finished? Getting your device cleared is a major victory, but your regulatory obligations continue. A great consulting partner can provide ongoing support for post-market surveillance, help you review marketing materials to ensure they remain compliant, and assist with reporting any adverse events. They can also help you strategize for future product updates or expansion into international markets. Maintaining this relationship ensures you stay compliant as your company grows and regulations change.