Kobridge Consulting assist medical device companies in obtaining CE Marking, implement ISO 13485 or GMP quality systems, submit applications to North America (US and Canada), and more.
The mission of Kobridge Consulting is to assist companies with most international quality and regulatory compliance issues, or if needed to outsource Regulatory Affairs and Quality Assurance (RA/QA).
The expertise of Kobridge Consulting is based on a solid experience in regulatory and quality audits, technical files submission and review as well as process improvement. Kobridge Consulting is also very active in Europe as it is acting as a subcontractor for audits of medical device manufacturers on behalf of European Notified Bodies.
Examples of workflow :