Permanent medical implant safety compliance confirmed.

Zwiers Regulatory Consultancy finalized its evaluation of the safety of the Parx Materials technology in medical devices according to the applicable standards (ISO 10993) and Regulation (EC) No 1907/2006. 

Zwiers Regulatory Consultancy reviewed (i) data on safety aspects (material safety data sheets, and several well-known databases and (ii) biological safety evaluation test results. The outcome was that the starting and reaction materials applied are well-known and can be used to further process as part of a medical device. Parx Materials technology is using medical grade materials which comply with the monographs of international pharmacopoeias (EP/ USP).   

About Zwiers Regulatory Consultancy 

Zwiers Regulatory Consultancy provides full regulatory and pharmacovigilance support, throughout the entire product lifecycle. Besides medicinal products, Zwiers Regulatory Consultancy also supports the development of medical devices and IVDs.