ISO 13485 Medical Devices

ISO 13485 Medical Devices

For ISO 13485 Medical Devices Quality Management Systems, International Associates have just had a large extension to scope for Accreditation granted by the United Kingdom Accreditation Service (UKAS) that covers category A.1.7 of IAF MD 9. This extension to scope is quite substantial and covers the following activities:

  • Raw Materials: Raw metals, plastic, wood & ceramic
  • Components: Electrical components, fasteners, shaped raw materials, machined raw materials & molded plastic
  • Sub-Assemblies: Electronic sub-assemblies, mechanical sub-assemblies, made to drawings & work instructions
  • Calibration Services: Verification/confirmation services for measuring instruments, tools or test fixtures
  • Distribution Services: Distributors providing storage and delivery of medical devices, not acting as a ‘legal manufacturer’ for medical devices
  • Maintenance Services: Electrical or mechanical repair services, facility cleaning  & maintenance services, uniform cleaning  & testing of ESD smocks
  • Transportation Services: Trucking, shipping, air, transportation service in general
  • Other Services: Consulting services related to medical devices & packaging services

In addition to the new approvals above the following:

  • General Non-Active, Non-Implantable Medical Devices: Non-active devices for anaesthesia, emergency & intensive care, Non-active devices for injection, infusion, transfusion & dialysis, Non-active orthopedic & rehabilitation devices, Non-active medical devices with measuring function, Non-active ophthalmologic devices, Non-active instruments, Contraceptive medical devices, Non-active medical devices for disinfecting, cleaning, rinsing, Non-active devices for in vitro-fertilisation (IVF) and assisted reproductive technologies (ART) & Non-active medical devices for ingestion.
  • Non-Active Implants: Non-active cardiovascular implants, Non-active orthopedic implants, Non-active functional implants & Non-active soft tissue implants
  • Devices for Wound Care: Bandages and wound dressings, Suture material and clamps, Other medical devices for wound care.
  • Non-Active Dental Devices & Accessories: Non-active dental devices/equipment & instruments, Dental materials & Dental implants
  • Other Non-Active Medical Devices

For all enquiries in relation to UKAS Accredited ISO 13485 Certification of your Medical Device Quality Management System please send an email to enquiry@ia-uk.com or call +44 (0)1413 28 29 28

 

 

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