![]() An ISO 13485:2016 compliant system expedites access into those countries that require it. Regulatory authorities in most major markets like European Union, United States, Canada, Japan, and Taiwan require, or strongly prefer, that manufacturers marketing medical devices in their countries have a third-party audited and certified Medical Device Quality Management System in place. ISO 13485:2016 Certification is a solution for this issue!!! ![]() ![]() ![]() ![]() Medical Device component manufacturers, finished good manufacturers, Medical Software developers, Medical Device designers and Developers, and pharmaceutical suppliers interested in enjoying worldwide presence must prove their devices are manufactured under certain auditable standards, which means it’s safe and effective. ![]()
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