23 Jul

ISO 13485:2016 Certification Announcement

ISO 13485:2016 Certification Announcement
The ISO 13485:2016 Quality Standard is internationally recognised and may be awarded to medical device manufacturers who demonstrate excellence in quality management and best practice the design, manufacture and supply of prosthetics and orthotic products.

MDSAP is recognised by the International Medical Device Regulators Forum whose member countries include Australia, Brazil, Canada, Japan and the USA. 

These internationally recognised standards ensure that Steeper upper limb prosthesis products are offered globally and that all devices manufactured by Steeper across the fields of Prosthetics and Orthotics meet these exacting standards.  
“We’re incredibly proud of this achievement; our quality, research and development and production teams hold our products to the highest standard as is expected by our clinical customers and device users. The 13485 and MDSAP quality standards recognise this. The award of these certifications is a key success factor for Steeper, marking the start of our journey in maintaining and upholding these certifications for business growth and expansion for years to come.” said Paul Steeper, CEO.

This is something to be celebrated as this process can often take organisations 2-3 years to complete. Moreover, completing this around the Steeper 100th year anniversary has made it extra special! What's more, the transition work of the MDD93/42/EEC to MDR 2017/745 running alongside this activity, has made it even more satisfying.