Expert Medical Device Regulatory Consulting

How We Work

At QCC, we build long-term partnerships with our clients and deliver medical device regulatory consulting services tailored to your team and development stage. We give your organization the time and focused attention needed to navigate the regulatory submission process effectively.
 
Drawing on decades of experience in the medical device industry, we guide your team through evolving regulatory requirements specific to your device, intended use, and target market. We meet your team where they are, without introducing new tools or systems into your environment, and keep regulatory filings lean while supporting efficient clearance timelines.

Our process includes:

1. Discovery

   Once you contact us, we conduct an initial discussion to understand your device, commercialization objectives, team structure, and work environment. We then deliver a proposal that outlines a project plan aligned with your needs, timelines, internal capabilities, and current regulations and standards.

2. Documentation

   We guide your team through every stage of preparing and compiling the required technical documentation. As needed, we support cyber security medical devices by providing medical device cyber security guidance aligned with your device architecture, risk profile, and applicable regulatory expectations.

3. Document Filing

   We prepare your documentation for on-time submission and support your team in responding to requests for additional information from FDA or international regulatory agencies.