We're a team of medical device development experts.
We leverage decades of medical device and combination product experience to provide your organization with medical device consulting services that meet the expectations of FDA and other regulatory bodies.
CMD's mission and vision focus on improving the lives of patients and caregivers around the world. We accomplish this by implementing practical solutions that are "right sized" and focused on getting safe and effective products to market (and keeping them there)!
Why you'll love working with us:
Value
We've assembled a team of medical device consultants and maintain a substantial internal knowledge database to help our clients get to the finish line the most efficient way possible. Our goal is to build lasting relationships with our customers by exceeding expectations on every project and every engagement.
Quality
Whether it's developing a quality system for you, or leveraging our own (certified to ISO 13485:2016), our quality principles are based on ease-of-use and a focus on what's most important: the safety and security of devices and the people who use them. We pride ourselves on our ability to integrate the complex mix of regulations, standards, and guidance into a comprehensive quality management system that's easy-to-follow and implement.
Team
Every engagement with CMD gives you access to the collective knowledge and experience of our talented team. Our processes include best-practice sharing and the ability to consult with subject matter experts in a variety of different areas. You're not hiring an individual-- you're hiring a team!
Medical Device Engineering Leadership
Our crew brings extensive medical device engineering experience to a variety of challenging medical device and combination product development efforts. We provide systems engineering and technical leadership for our customers in the following areas, and can team up with our partners to offer true end-to-end product development under a Quality System certified to ISO 13485:2016.
Safety Risk Management : Cybersecurity and Cybersecurity Risk Management : Compliance Program Leadership (e.g., IEC 60601-1, IEC 62304, IEC 62366-1) : Requirements Development (User and Stakeholder Needs, System Requirements, Software Requirements) : Verification : Validation : Human Factors
Regulatory
Our regulatory team leverages our cross-cutting medical device and combination product experience, several RAPS Regulatory Affairs Certifications (RAC, RAC-US), and a multitude of direct interactions with FDA and Notified Bodies to bring you practical approaches to dealing with medical device and combination product regulations. Our EU and FDA regulatory consulting teams work well in the "grey" area of regulation, standards, and guidance. Our typical regulatory engagements include:
Q-Submissions / Pre-Submissions : 510(k) Preparation and 510(k) Submissions : eSTAR : De Novo Submissions : 513(g) Requests : Regulatory Strategies : Remediation : Technical File Construction : Design History File (DHF) Development and Maintenance : Device Master Record (DMR) Management
Quality and Quality Systems
Our decades of experience in contract R&D and medical device consulting has provided us with the unique opportunity to implement right-sized medical device quality systems using a risk-based approach. One size quality system does not fit all! We pride ourselves on quality services that ensure compliance with standards, regulations, and guidance in a practical, easy-to-follow manner. We have developed our own 21 CFR Part 11 compliant electronic document control system, "Astro," as an affordable and simple solution for small- to medium-sized medical device companies (including ourselves!). Our quality services include:
Medical Device Quality System Development (21 CFR 820, ISO 13485) : Quality System Management : Quality System Certification : Document Control : Electronic Document Management Systems (21 CFR Part 11 Compliant) : Audit and Inspection Support : Quality System Training
Project Management and Program Management
Our project and program managers bring decades of medical device and combination product experience to plan and execute complex product development efforts. Our strength lies in the combination of our management expertise with our extensive experience in technical product development, regulations, guidances, and consensus standards. Our team excels in driving communication within an organization, with multiple development partners, and with third parties (e.g., IEC 60601-1 and biocompatibility testing) to get products on the market efficiently. Our team helps you plan a comprehensive program budget and schedule, minimizing surprises and unforeseen hurdles. Our services include:
Schedule : Budget : Program Risk Management : Earned Value / EVMS : KPI Development and Tracking : Due Diligence Assessments : Acquisition Support
CMD is a Woman-Owned Small Business and an active member of:
