Commitment to Quality

Medovations is a global medical device design, manufacturing, and marketing company with over 30 years of experience in medical devices. Medovations operates under a Quality Management System that is compliant with the requirements of worldwide regulatory systems, including ISO 13485, United States FDA Code of Federal Regulations Title 21 Part 820 Quality System Regulations, European Union’s Medical Device Directive 93/42/EEC, and Health Canada’s Medical Devices Regulations SOR/98-282. The Medovations Quality System is regularly audited to these standards, and maintains ISO and CMDCAS certification.

ISO 13485