Medical Device Product Development & Design Control Consulting

Turn Innovation into FDA-Compliant, Market-Ready Products

From Concept to Commercialization—We Guide You Every Step of the Way

Developing a medical device is more than just engineering a solution—it’s about building a safe, effective, and FDA-compliant product. At [Your Company Name], we help you navigate the entire product development lifecycle with a focus on design control, regulatory compliance, and commercialization success.

Whether you’re launching your first Class II device or optimizing a complex system, our team ensures your development process aligns with FDA 21 CFR Part 820 and ISO 13485 requirements—without slowing your innovation.

Why Design Control Matters

Design control is not just a regulatory box to check—it’s the backbone of a successful medical device. Without it, you risk:

  • Costly product redesigns

  • Regulatory delays

  • Market rejections

  • Patient safety issues

We provide the structure, strategy, and systems to help you avoid these risks—while accelerating time to market.

Our Services

🔹 Product Development Planning

  • Project scope and timeline creation

  • Regulatory pathway alignment (FDA, EU MDR)

  • Cross-functional development team setup

  • Risk management strategy (ISO 14971)

🔹 Design Control System Implementation

  • SOPs for design input, output, review, verification, validation, and transfer

  • Requirements traceability matrix (RTM)

  • Design history file (DHF) creation and maintenance

  • Integration with your quality management system (QMS)

🔹 Verification & Validation Support

  • Test plan design and protocol review

  • Usability engineering and human factors analysis

  • Software validation (for SaMD and embedded systems)

  • Coordination of pre-clinical or clinical evaluations

🔹 Design Transfer to Manufacturing

  • Production specifications and assembly process documentation

  • Design transfer protocols and tech transfer checklists

  • Supplier qualification and manufacturing readiness

🔹 Remediation & Gap Analysis

Already have a system in place? We perform a detailed gap analysis to ensure your documentation meets FDA, ISO, and Notified Body expectations.

Who We Help

  • Startups launching their first device

  • Growing companies developing SaMD, wearables, or diagnostics

  • Established manufacturers updating legacy systems or scaling new designs

  • Organizations seeking to integrate agile or lean product development

Why Clients Choose [Your Company Name]

✅ Deep regulatory knowledge (FDA, ISO, EU MDR)
✅ Cross-disciplinary team of engineers, scientists, and QA/RA experts
✅ Hands-on, practical approach—no generic templates
✅ Proven success with FDA inspections, audits, and 510(k) submissions
✅ Scalable systems designed for real-world use

Make Compliance a Competitive Advantage

Let’s build your next breakthrough device—on time, on budget, and audit-ready. Partner with [Your Company Name] for expert product development and design control that reduces risk, ensures compliance, and drives market success.

📞 Book a Free Strategy Call Today
Let’s talk about your product and how we can streamline your development.