Management Systems
Unrivalled experience supporting you (re-) design, document, implement & maintain your EN ISO 13485:2016 Quality Management System to:
- address, integrate and meet EC MDR & IVDR and other national regulations / requirements / standards
- ensure efficiencies in management, processes, personnel, materials / supply chain, operations and distribution to suit your business, services and products
- reduce business and user / patient risk
- provide the necessary data to enable market surveillance & vigilance
- continually appraise and improve performance
- maintain your systems certifications and clearances to market.
Incorporating & embracing specific country requirements such as:
The Medical Device Single Audit Program (MDSAP)
Japan MHLW Ordinance No. 169, (QMS Ordinance)
USA FDA CFR820
Brazilian Good Manufacturing (BGMP) Certification
China Good Manufacturing Practice for Medical Devices
Mexico GMP Requirements & Technovigilance
Improving people, products/services, user experience, processes & systems for business advantage. Supporting you drive, maintain & develop your QMS (see In-House Expertise) and deliver Training in Quality Systems including EN ISO 13485:2016, CFR 820 and other countries GMP Requirements.