Quality and Regulatory
Under the management of the Group Quality Assurance/Regulatory Affairs Director, each of our sites has a professional Quality and Regulatory team responsible for ensuring that all site activities are fully compliant with prevailing regulations. Our in-house quality operations include world class analytical and microbiological laboratories that perform quality analysis of our raw materials, part and fully manufactured products. Quality Engineers and Validation Engineers support the R&D and operations function from product inception through to full product development and commercialisation. Our quality systems staff manage, operate and engage in continual improvement of our Quality Management System.
Our Regulatory Affairs department has worldwide regulatory experience, having supported regulatory registrations in over seventy different countries in Europe, North America, South America, Africa, Asia and Australia. Working closely with agents, partners and Regulatory Authorities, enables successful registrations and renewals of both our and our partner’s applications for market approval and of our medical devices. Our Regulatory Affairs department supports registrations of both newly developed products and for any product changes.
Our Quality and Regulatory teams work closely with the relevant Notified Body to ensure that all our sites are compliant with new legislations, that the products are safe and efficacious and to ensure that we maintain Quality Management Certification and CE Certification.
Certification
We have been awarded Quality Management Certification as well as CE Certification for all sites and products, demonstrating that we conform and work to best practices applicable to maintaining this certification.
Winsford CE Certificate (BSI)
ISO 13485 Certificate Winsford (UK)
Plymouth CE Certificate (BSI)
ISO 13485 Certificate Plymouth(UK)
Etten-Leur Certificate (LRQA)
ISO 13485 Certificate Etten-Leur
RESORBA® Certificate (TÜV)
Haifa, Israel (Sealantis) Certificate (DEKRA)
Nantes, France (Biomatlante) Certificate (TÜV)
MDSAP Cartificate Nantes (France)
