Vision Engineering achieves ISO 13485:2016
19th July 2021
Medical devices – Quality management systems Requirements for regulatory purposes
LONDON, 13 July 2021: Vision Engineering, a 63 year old British leading designer and manufacturer of high-quality visual measurement and inspection technologies, has attained ISO 13485:2016 and EN ISO 13485:2016 accreditation from the British Standards Institution (BSI) and is now a BSI accredited contract manufacturer 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 all the requirements to manufacture medical devices and components and builds on the ISO9001:2015 quality systems already in place at Vision Engineering.
Modern Manufacturing Facilities
Vision Engineering’s full service modern manufacturing facility includes design, machine shops, paint shop, clean room and assembly. It is replicated in the USA, with a wholly owned full service manufacturing facility in Connecticut.
In addition to its manufacturing services capability, Vision Engineering supplies 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, Vision Engineering comments:
“We are delighted to be awarded the ISO standard ISO 13485:2016 for our manufacturing facility. This ISO standards confirmation 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.”