Advanex Europe has recently announced that they have been successful in achieving the medical certification ISO13485 – the world’s most recognised medical device standard.
Based in Nottinghamshire, Advanex manufacture millions of springs and other precision metal components for the global medical device market. The team has ambitious growth plans for the years ahead and recognised that obtaining the certification would be instrumental in demonstrating regulatory and system compliance to medical and pharmaceutical customers.
The team have been working hard to obtain the certification which covers the medical and pharmaceutical manufacturing hall and associated support functions at the Southwell site.
In particular, the approval recognises that Advanex Europe:
- Has senior management that are involved and dedicated to quality
- Are firmly committed to meeting customer expectations
- Focuses on risk management and strict design and change controls
- Has controls in the work environment that ensure product conformance and safety
Paul Clifford, Managing Director explains, “We are extremely pleased to have achieved the ISO13485 certification. We are passionate about working with our medical and pharmaceutical customers in maintaining regulatory compliance. The certification has been the next logical step from our GMP compliance and has helped us to ensure that we are delivering the best possible service to our customers across the globe. Our talented teams remain firmly committed to working in partnerships with our clients to nurture device innovation and production efficiencies”.