Exact Medical Manufacturing, Inc. is pleased to announce that in addition to being certified through our China JV that EMM-New York is now also certified to quality standards;
- EU Medical Device Directive 93/42/EEC
- ISO 13485 – Medical devices — Quality Management Systems — Requirements for regulatory purposes.
These certifications are issued by TUV SUD Product Service GmbH, Notified Body Identification Number 0123.
Exact Medical Manufacturing – New York along with our EU Authorized Representative Exact Medical Manufacturing B.V. are now registered within the European Union Competent Authorities along with USA FDA registrations for our USA and China operations.