J&J Consulting Group- FDA Regulatory Compliance
- 1101 California Ave Suite 100 Corona CA 92881
- Info@jjccgroup.org
- (800) 999-7781
Medical Device Regulatory Consulting
Call for Appoinment
949 735 6224
Regulatory Experts
Medical Device Regulatory Strategic Partner
FDA’s Quality Management System Regulation (QMSR) took effect on Feb 2, 2026. Part 820 now incorporates ISO 13485:2016 by reference and adds FDA-specific requirements. FDA has retired its QSIT inspection technique and now inspects device makers against the QMSR. JJCC Group helps you close the gap and prove it on inspection day.
Process Excellence
Quality Assurance & Quality Control
To assess your manufacturing processes, risk management, audits, inspections, and responses to regulatory agency actions, the JJCC group provides the expertise you need. The FDA requires thorough documentation to prove the efficacy, handling, shipping, and much more of your product. With over 30 years of industry knowledge, JJCC group ensures your processes meet regulatory standards every step of the way.
FDA's own quality system requirements
ISO 13485:2016 incorporated by reference (section 820.10)
DMR, DHF and DHR
Medical Device File and ISO 13485 records, plus section 820.35 record requirements
Management review, internal audit and supplier audit reports shielded from FDA
Management review, internal audit and supplier audit reports shielded from FDA
Risk management implied
Risk management expected across the QMS (ISO 13485 clause 7.1; ISO 14971)
- Quality Management System (QMS) Development and Implementation
- Gap Analysis & Compliance Audits
- Internal Audits & Pre-Certification Assessment
- Documentation & SOP Development
- Risk Management (ISO 14971 Alignment)
- Design & Development Controls
- Supplier & Vendor Qualification
- CAPA (Corrective and Preventive Action) Systems
- Management Review & Quality Objectives
- Post-Market Surveillance & Complaint Handling
- Regulatory Strategy & Submissions Support
- Employee Training & Competency Development
- Certification Body Liaison & Audit Support
- Ongoing Compliance & Maintenance Support
Risk Control
ISO 13485 for medical devices
Achieving ISO 13485 certification is a complex, resource-intensive process that demands deep regulatory expertise and a structured quality management approach. At JJCC Group, we deliver tailored ISO 13485 consulting strategies designed to simplify compliance and accelerate your path to accreditation. Our experienced medical device consultants partner with manufacturers, startups, and established organizations to ensure every requirement of the ISO 13485:2016 standard is met with precision.
We provide end-to-end support across all critical areas of medical device development and quality management, including but not limited to:
Strategy
Navigating the New FDA Quality Management System Regulation (QMSR)
The medical device industry is entering a transformative era with the FDA’s new Quality Management System Regulation (QMSR), set to take full effect on February 2, 2026. The QMSR replaces the long-standing 21 CFR Part 820 framework and harmonizes U.S. medical device quality requirements with the globally recognized ISO 13485:2016 standard. This landmark shift streamlines compliance for manufacturers operating across international markets, reducing redundancy between FDA expectations and global regulatory frameworks. For medical device companies, the QMSR represents both a significant opportunity and a critical compliance challenge — one that requires careful planning, system updates, and a thorough understanding of where ISO 13485 and FDA-specific requirements intersect.
At JJCC Group, our regulatory consultants specialize in guiding medical device manufacturers through the transition to the new QMSR with confidence and clarity. We help organizations assess their current quality management systems, identify gaps between existing 21 CFR Part 820 processes and the updated QMSR requirements, and implement practical, audit-ready solutions. From updating documentation and SOPs to retraining personnel and aligning risk management practices with ISO 14971, our team ensures your QMS is fully prepared before the enforcement date. Whether you’re a startup launching your first device or an established manufacturer managing a global portfolio, JJCC Group delivers the strategic expertise needed to turn QMSR compliance into a competitive advantage.
QMSR gap assessment
and remediation of your QMS to ISO 13485
Design and development controls
(ISO 13485 clause 7.3) and design history documentation
Risk management files
to ISO 14971:2019
510(k) support
pathway choice, predicate selection, testing plans and eSTAR preparation
Complaint handling
MDR reporting (Part 803) and corrections and removals (Part 806)
Classify
the device and choose the pathway: 510(k), De Novo or PMA
Build the QMS
and design controls in parallel with development
Test and document
biocompatibility, software, electrical safety, usability
Submit
and answer FDA's questions
See how we navigate every step of regulatory compliance efficiently
From Planning to Market
Comprehensive Regulatory Strategic Planning
Testimonial
What our clients say about JJCC
Trusted by medical device companies worldwide, JJCC ensures compliance, quality, and smooth market entry. See how we help our clients succeed.
"JJCC guided us through ISO 13485 and fda compliance seamlessly. Their expertise saved us time and ensured regulatory success."
Faqs
Frequently Asked Questions
At JJCC Group , we answer the most common questions about medical device regulatory compliance, quality assurance, and global market entry. Our expertise helps companies navigate complex regulations efficiently.
JJCC provides guidance on ISO 13485, FDA, CE marking, risk management, and staff training, ensuring your medical devices meet international standards and succeed in every market.
What is the QMSR?
The Quality Management System Regulation is FDA’s device quality rule in 21 CFR Part 820. It took effect Feb 2, 2026 and incorporates ISO 13485:2016 by reference.
Does the QMSR replace Part 820?
No. It amends Part 820. The old Quality System regulation text was replaced, but the rule still lives in Part 820.
If we are ISO 13485 certified, are we QMSR compliant?
Not automatically. The QMSR adds FDA-specific requirements for records, labeling and packaging, and FDA’s own definitions. FDA also does not accept ISO certificates in place of inspection.
What happened to the DMR, DHF and DHR?
The QMSR dropped those terms. Their content now lives in the Medical Device File and ISO 13485 records, supported by section 820.35.
Can FDA now see our internal audit reports?
Yes. Under the QMSR, management review, internal audit and supplier audit records are open to FDA inspection. Write them with that in mind.
How does FDA inspect device makers now?
FDA retired QSIT and inspects against the QMSR using a risk-based approach. Expect questions on risk management across all processes.
Is ISO 14971 required?
The QMSR does not name ISO 14971, but ISO 13485 requires risk management throughout product realization. ISO 14971 is the accepted way to do it.
Which pathway does my device need?
Most Class I devices are exempt from premarket review. Most Class II need a 510(k). Class III needs a PMA. Novel low-to-moderate risk devices may use De Novo.
What is a 510(k)?
A premarket notification showing your device is substantially equivalent to a legally marketed predicate. FDA clears, not approves, a 510(k).
How long does 510(k) review take?
FDA’s review goal is 90 FDA days. Hold time for your answers to FDA’s questions adds to the calendar time.
What is eSTAR?
FDA’s required electronic template for 510(k) submissions. It structures the submission and speeds FDA’s acceptance review.
Do device establishments register with FDA?
Yes. Device establishments register and list each year between Oct 1 and Dec 31 and pay the annual registration fee.
What is MDR reporting?
Under Part 803, manufacturers report deaths, serious injuries and certain malfunctions to FDA, usually within 30 calendar days.
What is UDI?
Unique Device Identification (Part 830) requires a UDI on labels and packages and submission of device data to FDA’s GUDID database.
Can you help us sell in Canada or the EU?
Yes. Canada requires MDSAP certification, and the EU requires CE marking under the EU MDR. We help align one QMS to all three.
What is MDSAP?
The Medical Device Single Audit Program lets one audit satisfy regulators in Australia, Brazil, Canada, Japan and the U.S.
Do you provide QMSR training?
Yes. We train staff on-site and through The cGMP Academy, with a course on each QMSR and ISO 13485 topic.
How long does QMSR remediation take?
A company already certified to ISO 13485 may need 2 to 4 months. A company moving from the old QS regulation alone often needs 6 to 12 months.
Official Guidelines
Trusted References & Regulatory
JJCC group bases its medical device compliance strategies on authoritative regulatory sources to ensure accuracy and reliability. These guidelines help companies meet global standards efficiently and safely.
Why Manufacturers Choose JJCC Group for Medical Device Regulatory Consulting Services
Bringing a medical device to market is one of the most heavily regulated undertakings in any industry, and the margin for error is thin. That’s why device manufacturers, startups, and established organizations alike turn to JJCC Group for medical device regulatory consulting services that cover the full spectrum of compliance, from early-stage strategy through post-market surveillance. Our team functions as an extension of your own, embedding regulatory discipline into every phase of your operation so that compliance becomes a competitive advantage rather than a roadblock.
JJCC Group has spent over three decades providing leading consultancy for medical device compliance, helping manufacturers translate complex, ever-changing regulations into practical, actionable roadmaps. Whether you’re pursuing ISO 13485 certification, preparing for FDA inspection, or expanding into new international markets, our consultants bring the hands-on experience needed to anticipate regulatory hurdles before they become costly delays.
Submission Support
Regulatory submissions are often where promising devices stall. A single gap in documentation, testing data, or labeling can trigger months of additional review, or result in an outright rejection. JJCC Group works alongside your team to prepare thorough, well-organized FDA submissions and international filings that anticipate reviewer questions and reduce back-and-forth. We understand what regulators are looking for because we’ve spent years on both sides of the review process, and we apply that insight to strengthen your submission packages from the outset.
Product Development
Our support doesn’t begin at the submission stage; it starts with product development. Building regulatory considerations into your design and development process early prevents expensive redesigns later. As your medical device regulatory consultant, JJCC Group reviews design inputs, verification and validation plans, and risk management documentation to ensure your product architecture aligns with FDA, ISO, and international requirements from day one.
Getting a device approved is only half the equation. Getting it into the hands of patients and providers requires a clear market access strategy. JJCC Group helps you sequence your regulatory approach across the U.S., Canada, the EU, and beyond, so that your regulatory approval timeline supports your commercial launch plans rather than working against them. We help you identify which markets to prioritize, what regulatory pathway fits your device classification, and how to avoid duplicating effort across jurisdictions.
Working With & For You
Companies searching for the best regulatory strategy consultants for medical devices are usually looking for more than a checklist. They need a partner who understands the operational realities of manufacturing, quality systems, and regulatory science together. That’s the difference JJCC Group brings. Our medical device consulting services are built around your specific device class, business stage, and target markets, not a one-size-fits-all template.
Your Reliable Partners in Compliance
If you’re evaluating medical device compliance consulting partners, we invite you to speak with our team about where your organization currently stands and where the biggest compliance risks and opportunities lie. From first-time device makers to multinational manufacturers managing global portfolios, JJCC Group delivers the regulatory clarity and hands-on support needed to move confidently from concept to market and to stay compliant long after launch. Reach out to us today to discuss your medical device regulatory consulting needs.
