This also comprises the facilities and designs applicable to these products. This document covers ‘The design, manufacture, packaging, labeling, storage, installation, and servicing of all finished products that are intended for human use’. You will need to comply with 21 CFR Part 820.Ģ1 CFR Part 820 cites the medical device Quality System Regulations (QSR) for medical device manufacturers. If you are selling your medical device products only in the US, you come under the rules and regulations of the US FDA. As a medical device company, you will need to pass the ISO 13485:2016 certification audit and acquire the CE mark before you can sell your products in the EU. How to Facilitate ISO 13485:2016 Compliance with QMS Software?Īn ISO 13485:2016 audit helps determine that the medical device company complies with an international standard acceptable in global regions such as the EU.Īll medical device companies that sell their products in the EU must pass an ISO 13485 audit that is conducted by a Notified Body.
How Are the ISO 13485:2016 Audits Conducted?.How to Prepare for ISO 13485:2016 Audits?.How Often is ISO 13485:2016 Auditing Done?.In this article we will take a deeper look at the following: All medical device companies wishing to sell their devices in the European Union (EU) must pass an ISO 13485:2016 audit that is conducted by a Notified Body. ISO 13485:2016 is the latest edition of ISO 13485, which, as we know is the principal international QMS (Quality Management System) standard for medical devices companies.
0 kommentar(er)
