iso 13485 consultant pune india, ISO 13485 Pune, Maharashtra, India- Iso Consultants leading ISO 13485 medical devices, ISO 13485 - Consultants India, ISO 13485 certification - ISO Delhi, best ISO 13485 consultants, ISO 13485 certification in delhi for ISO 13485, Largest ISO 13485 consultant in delhi for ISO 13485 certification, ISO consultant delhi ISO certificate delhi, ISO Consultants Delhi for ISO Certificate and ISO Training in Delhi providing ISO 9001 ISO 14001 OHSAS 18001 HACCP ISO 22000 ISO 17025 consulting in Bulandshahr and Faridabad, ISO Certification Ghaziabad, ISO Certification Gurgaon, ISO certification Hodal, ISO certification Khurja and ISO Certification Moradabad, iso 13485 certification in Delhi Mumbai Kolkata India, ISO 13485 Consultants in Delhi, ISO 13485 Certification Gurgaon |ISO Consultants Gurgaon, ISO 13485 Certification Services Delhi India, ISO 13485 certification in delhi, ISO 13485 certification in india, ISO 13485 certification bodies in mumbai, ISO 13485 certification bod in chennai, 13485 Certification Services, ISO 13485 Certification Consultants, ISO 13485 Certification Services in Gurgaon NCR, ISO 13485 Certification Services, ISO 13485 Certification Consultants noida, gurgaon, manesar, faridabad, RoHS Certification Consultants in Greater Noida Uttar Pradesh; RoHS- Certification Consultants Registration Services in Greater Noida Uttar Pradesh, ROHS MARK,ROHS marking,ROHS Marked, ROHS Mark Certification Consultants in Ahmedabads, RoHS Consultants - Consultancy - Certification Ahmedabad, Baroda, Mumbai, Pune, Delhi, Surat, Rajkot, Jaipur, Indore, Hyderabad, Chennai, Bangalore, RoHS Consultants,RoHS Consultants Ahmedabad Guajrat, RoHS Consultants,RoHS Consultants Ahmedabad Guajrat Mumbai India Rohs , RoHS WESTBANGOL- Kolkata, BIHAR- Patna, Gaya, JHARKHAND, RoHS Consultant Certificate RoHS RoHS Consultant RoHS Consultants ISO Consultant Ahmedabad Gujarat ROHS Certificate Consultant, RoHS consultants in Mumbai, Delhi, Bangalore, Hyderabad, Ahmedabad, Chennai, Rohs Certification Consultants in Ahmedabad, Rohs Certification Consultants in Sola, Ahmedabad ROHS Certification consultancy service in India, Andhra Pradesh,Chandigarh,Arunachal Pradesh, Rajasthan,West Bengal, ROHS certification Consultation in Hyderabad, RoHS Certification, RoHS Compliance in India punjab ludhiyana, amritsar, jalandhar, Rohs Consultants in Jalandhars, RoHS Consultants in PUNJAB

ISO 13485:2016 Certification

The European standard EN ISO 13485:2016 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, has been published, after approval by CEN on 24 January 2012. This replaces EN ISO 13485: 2016.

It is important to note that the text of the global standard ISO 13485:2016 is unchanged. Only the foreword and annexes in the European version have been revised. The revised standard will be available in the next few weeks.

EN ISO 13485, as the EU harmonised standard for medical device quality management systems, is an essential tool allowing medical device manufacturers to prove evidence of compliance to the European legislation.

During 2011, the European Commission raised an objection to the harmonisation status and the implied Presumption of Conformity of a number of European standards including EN ISO 13485. Sweden also raised a formal objection to the European Commission in February 2011 on the link between adhering to the standard and compliance to the Directives.

To restore confidence and bring back the presumption of compliance indicated by the harmonised status of the standard, it was essential to revise the Annexes ZA, ZB and ZC and add further details on the link between standards and the three Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC. All signs are clear for the new EN ISO 13485:2016 to be harmonised and this will most likely happen by summer 2016.

Benefits of ISO 13485:2016 Certification

How many certification bodies in India ISO Certification, ISO Certification Body in Kolkata who Provide ISO Certification Services in ISO 9001, ISO 14001, ISO 22000 and Ohsas 18001, iso certification consultancy, ISO Certification Bodies in Kolkata, ISO CONSULTANTS IN KOLKATA, ISO certification offers, in Kolkata, West Bengal, Orissa, ISO Certification Consultancy in Kolkata, ISO 9001 Consultants - ISO 9001 Certificate, ISO Certification Consultants, ISO CONSULTANTS IN KOLKATA, ISO 9001:2015 Certification, ISO 9001 Quality Management Consultants in Kolkata, ISO Certification Consultants in Kolkata, ISO9001:2015, CONSULTANCY, ISO, 9001, 9000, 14001, 9001:2000,OHSAS, HACCP, ISO Consultants in Kolkata, ISO Consulting Services Kolkata, iso 13485 consultant pune india, ISO 13485 Pune, Maharashtra, India- Iso Consultants leading ISO 13485 medical devices, ISO 13485 - Consultants India, ISO 13485 certification - ISO Delhi, best ISO 13485 consultants, ISO 13485 certification in delhi for ISO 13485, Largest ISO 13485 consultant in delhi for ISO 13485 certification, ISO consultant delhi ISO certificate delhi, ISO Consultants Delhi for ISO Certificate and ISO Training in Delhi providing ISO 9001 ISO 14001 OHSAS 18001 HACCP ISO 22000 ISO 17025 consulting in Bulandshahr and Faridabad, ISO Certification Ghaziabad, ISO Certification Gurgaon, ISO certification Hodal, ISO certification Khurja and ISO Certification Moradabad, iso 13485 certification in Delhi Mumbai Kolkata India, ISO 13485 Consultants in Delhi, ISO 13485 Certification Gurgaon |ISO Consultants Gurgaon, ISO 13485 Certification Services Delhi India, ISO 13485 certification in delhi, ISO 13485 certification in india, ISO 13485 certification bodies in mumbai, ISO 13485 certification bod in chennai, 13485 Certification Services, ISO 13485 Certification Consultants, ISO 13485 Certification Services in Gurgaon NCR, ISO 13485 Certification Services, ISO 13485 Certification Consultants noida, gurgaon, manesar, faridabad, Ahmedabads, RoHS Consultants - Consultancy - Certification Ahmedabad, Baroda, Mumbai, Pune, Delhi, Surat, Rajkot, Jaipur, Indore, Hyderabad, Chennai, Bangalore, RoHS Consultants,RoHS Consultants Ahmedabad Guajrat, RoHS Consultants,RoHS Consultants Ahmedabad Guajrat Mumbai India Rohs , RoHS WESTBANGOL- Kolkata, BIHAR- Patna, Gaya, JHARKHAND, RoHS Consultant Certificate RoHS RoHS Consultant RoHS Consultants ISO Consultant Ahmedabad Gujarat ROHS Certificate Consultant, RoHS consultants in Mumbai, Delhi, Bangalore, Hyderabad, Ahmedabad, Chennai, Rohs Certification Consultants in Ahmedabad, Rohs Certification Consultants in Sola, Ahmedabad ROHS Certification consultancy service in India, Andhra Pradesh,Chandigarh,Arunachal Pradesh, Rajasthan,West Bengal, ROHS certification Consultation in Hyderabad, RoHS Certification, RoHS Compliance in India punjab ludhiyana, amritsar, jalandhar, Rohs Consultants in Jalandhars, RoHS Consultants in PUNJAB