We are delighted to announce that we have achieved certification to ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes, and EN ISO 13485:2016 from BSI for our manufacturing facility including the manufacture of mechanical, electronic, electrical, and optical medical assemblies and components.
The ISO 13485:2016 standard is an internationally recognized standard of quality and safety for the medical device industry and provides stringent guidelines for medical device manufacture. The certification process recognizes that Vision Engineering meets Quality Management System standard for the manufacture of medical devices and components and builds on the ISO9001:2015 quality systems already in place at Vision Engineering.
Our full service modern manufacturing facility includes design, machine shops, paint shop, clean room and assembly. This is replicated in the USA, with a wholly owned full service manufacturing facility in Connecticut.
In addition to our manufacturing services, we supply non-contact and contact optical and digital microscopy and measuring systems to a wide range of global manufacturers, including medical device, aerospace, automotive, defence and their multi-tier supply chains.
Mark Curtis, Managing Director, comments:
“We are delighted to be certified against ISO 13485:2016 for our manufacturing facility. This certification is a key statement of our ability to address the requirements of our manufacturing customers across the world and provide certainty of the quality of mechanical, electronic, electrical, and optical medical assemblies and components.
It will help enormously in our worldwide business with medical device companies and also with Vision Engineering’s Manufacturing Services business line for wider sub contract manufacturing opportunities.”