Press Release
It is part of Exact Medical Manufacturing’s long term strategy to invest significantly into our Quality System. The goal with this investment is to give our existing customers confidence and security in the products we supply to them and to become a more attractive potential supplier to our prospective customers.
To this end EMM is pleased to announce three (3) significant quality and regulatory accomplishments during 2017.
- January – 2017: EMM-NY (USA) successfully completed audits by TUV-SUD for certification to EU Medical Device Directive 93/43/EEC for CE Certification and ISO 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.
- April – 2017: EMM-CN (China) successfully completed audits by TUV-SUD for certification to ISO 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.
- November – 2017: EMM-NY (USA) successfully completed audits by the USA Food & Drug Administration base upon regulation 21CFR820, Quality System Regulation (QSR).
These three accomplishments specific to EMM’s quality systems provide for a quality compliance capability which is strong, continuous and reliable for our customers, end users and EMM operations.
