Bilal Chamas
Expert Medical Device Regulatory Affairs Consultant | 12+ Years Global Experience | PMA, 510(k), EU MDR
Bilal Chamas is a highly accomplished and strategic Regulatory Affairs professional with over 12 years of dedicated experience in the medical device industry. As a critical thinker and exceptional communicator, he excels at building strong cross-functional teams and driving global regulatory success. His expertise spans the entire product lifecycle, from initial development through post-market surveillance, with a proven track record in navigating complex global regulatory pathways. Bilal excels in project management, strategic planning, and ensuring robust compliance with international regulations, making him an invaluable asset to any medical technology company seeking to achieve market access and maintain regulatory integrity.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), PMA
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
12
Num510k Submitted:
30
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, neurology, ophthalmic, general-hospital
Technology Types:
implantable
Accepting New Clients:
No
