Alpine Quality Consultants provides guidance & support for certification by highly qualified, experienced and professional (Subject Matter Experts) with respect to ISO and CE Certifications. We support our clients to prevent & resolve compliances problems:
Medical Device QMS and MDQMS (ISO) Certification Consulting
- Quality Management System: ISO 9001:2015
- Quality Management System for Medical Devices: ISO 13485:2016
- Environment Management System: ISO 14001:2015
- Occupational Health and Safety Management System: OHSAS 18001:2007
Indian Certification for Medical Devices
- Indian Certification of Medical Devices- Technical Criteria for Certification of Medical Devices – ICMED 9000
- Indian Certification of Medical Devices- Technical Criteria for Certification of Medical Devices – ICMED 13485
CE Mark for Medical Devices
- CE Marking for Medical Devices For Class I, Is, Im, IIa and IIb as per (Directive 93/42/EEC)
- CE Marking for in-vitro Diagnostic Medical Devices as per (Directive 98/79/EC)
Transition EU MDR
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MDR 2017-745. Medical devices
(on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC)
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IVDR 2017-746 In-vitro diagnostic medical devices
(on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU).