FDA, European Union and Health Canada Regulatory/QMS Checklist

Regulatory surprises are expensive. Discovering a gap in your quality management system or an undefined intended use statement mid-development can derail timelines, inflate costs, and delay market entry.

The StarFish Medical Regulatory and QMS Checklist gives medical device companies a structured way to assess their regulatory readiness against the StarFish Product Development Process. Work through it at any stage of development to identify what you have covered, what is missing, and what needs attention before it becomes a problem.

Your Regulatory Checklist Questions, Answered

What is the purpose of the StarFish Medical regulatory checklist?
The checklist is a self-assessment tool that helps medical device companies evaluate their commercialization readiness against applicable regulatory requirements across the FDA, Health Canada, and the European Union. Results are mapped to stages of the StarFish Product Development Process to identify gaps.

Why does intended use matter so much for regulatory classification?
Intended use directly determines a device’s risk classification and regulatory pathway. The same underlying technology can fall into entirely different risk classes depending on how it is used. An oximeter intended for home spot-checking is Class II under Health Canada, while the same technology used for continuous inpatient monitoring is Class III, and an intracardiac version is Class IV.

When should a medical device company establish a Quality Management System?
A QMS covering design controls should be in place at the start of the product realization phase, which corresponds to Alpha and Beta device development. A full QMS including GMP and manufacturing controls is required before transfer and pilot manufacturing. Companies pursuing CE marking should note that an ISO 13485 QMS alone is not sufficient; compliance with the EU MDR must also be demonstrated.

What is the difference between a National Coverage Determination and a Local Coverage Determination for FDA-regulated devices?
This question belongs to the reimbursement white paper rather than this checklist. For regulatory classification questions, the checklist distinguishes between FDA pathways such as 510(k), PMA, and De Novo, each of which applies to different device classes and risk profiles.

What regulatory pathway applies to a Class II FDA device?
Most Class II devices pursue 510(k) clearance, which requires the identification of a substantially equivalent predicate device. De Novo classification is available for novel low-to-moderate risk devices without a suitable predicate. Class II exempt devices do not require premarket submission but must still comply with general controls.

At what stage should target markets and regulatory pathway be defined?
Target markets, intended use, device risk class, and regulatory pathway should all be well understood before the end of the Proof of Concept phase. These inputs are also essential for developing a business plan and are often required by investors before Series A funding discussions.

How does the EU MDR differ from ISO 13485 for CE marking purposes?
ISO 13485 establishes the framework for a quality management system, but EU MDR compliance requires demonstrating that the device itself meets the General Safety and Performance Requirements of the regulation. For Class II devices and above, both a conforming QMS and documented MDR compliance are required; ISO 13485 certification alone is not sufficient for CE marking.