Asaf Omer
Senior QARA consultant
Asaf Omer, Industrial and management engineer has been in the medical device industry for over 27 years, and has over 25 years experience in establishing, maintaining and developing medical device quality management systems that meets regulatory requirements, both as an external consultant and as an in-house QA&RA lead. Asaf has extensive experience in working with various types of medical device developers and manufacturers towards meeting worldwide regulatory requirements such as FDA (510(k), De-Novo), EU (MDR/IVDR), South East Asia and South and Central America.
Additionally, Asaf has over 20 years of expertise in auditing quality systems in accordance with ISO 9001, ISO 13485, and 21 CFR part 820, including conducting mock FDA and CE audits.
