Regulatory Basics for Medical Startups: A Simplified Guide
Navigating regulatory compliance is a crucial challenge for medical startups. Understanding global market regulations, device classifications, and submission pathways can streamline the approval process and ensure market readiness.
Key Regulatory Considerations
Global Market Landscape: The U.S. dominates the medical device market, but planning for international compliance early can simplify future expansion.
Medical Device Classification: Devices fall into Class I (low risk), Class II (moderate risk), or Class III (high risk), determining the regulatory requirements.
FDA Submission Pathways: 510(k) (for equivalent devices), De Novo (for novel devices), and PMA (for high-risk devices) dictate approval requirements.
Regulatory Compliance Essentials
Quality Management Systems (QMS): Compliance with FDA (21 CFR Part 820) and ISO 13485 is essential.
International Regulations: The EU MDR and other global frameworks require specific certifications and documentation.
Common Pitfalls: Delaying compliance planning, underestimating costs, and neglecting post-market obligations can hinder success.
About The Author
Darrell Drysen has over 25 years of experience in the Medical Device, Life Science, and Bio-Tech industries. As a technical leader, he holds patents in several fields including Brachytherapy, Electrophysiology, and Neurovascular implants. His outstanding ability to lead projects is evident from the numerous products he has taken from from concept through commercialization for both large companies and starts-ups. He joined ThermoGenesis in 2019 and is currently the Vice President of Operations.
Darrell holds certificates and degrees in Plastics Engineering Technology, Project Management, and Business Administration from California State University Sacramento and Cal Poly Pomona.
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