30+ Years in the Medical Device Industry Medical Device Regulatory Affairs + EU MDR
Getting your Medical Devices to Market
Consulting Experience
Quality Assurance
Much experience with helping start-up companies implement, obtain, and maintain accreditation to ISO 9001 and ISO 13485 since the early 90s and compliance with US FDA cGMP (21 CFR Part 820 Quality System Regulation). Now familiar with ISO 13485 MDSAP accreditation, especially for Canada and the USA
Regulatory Affairs
Plenty of experience writing, submitting, obtaining, and maintaining Canadian Medical Device Licensing, European CE Marking, and US FDA 510(k)/PMA for many types of medical devices including cardiovascular implants, neurovascular implants, and orthopedic implants. Also familiar with standalone software and medical devices containing software
Testimonials
Ailsa Biomedical Regulatory Consulting
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