RegPro Medical

No matter where in the world you will sell your Medical Device, there are regulatory requirements for a Quality Management System or “QMS”, also sometimes called Good Manufacturing Practices “GMP”.   The International Regulatory standard for medical device QMS is ISO 13485, recognized and/or required in most countries worldwide. Achieving certification to ISO 13485 through an accredited certification body will be required for marketing and selling your device in most counties. Additional MDSAP certification is required to sell in Canada, and is an optional certification advantage in the USA, Australia, Brazil, and Japan.  To achieve this, you will need documented procedures that are customized to your specific medical device and your specific organization.