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

• 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)

• 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).