PPEs intended for Medical Use are categorised as Medical Devices wef 1st April 2020 and hence subject to MDR 17.
Chennai based Mgmt Systems Consultants Association has taken up the massive exercise of Training Manufacturers of PPEs, intended for Medical Use, on Quality Management Systems Certification based on ICMED 9000 and ICMED 13485 Certifications, the two National Certification Schemes jointly developed by AIMED (Association for Indian Medical Device Industry and QCI – Quality Council of India.
Multiple batches are scheduled for regular training as PPEs intended for Medical Use are now categorized as Medical Devices under MDR 17 as per new Medical Device Definition released by CDSCO recently. All Medical Devices in the country are brought under Regulation wef 1st of April 2020.
Highly engaging sessions where Promoters are attending these sessions to learn more about ICMED Schemes, MDR 17 etc.
Any industry led, partnered Certification Schemes will have great acceptance in the market place as industry is the key stakeholder in maintaining & monitoring the Quality Practices in the mkt place.
Ownership and Accountability is with the Industry stakeholder too.
CCC has already initiated 2 batches for multiple manufacturers and continues with the roll out of subsequent batches too.
Sessions are handled by multiple trainers who are well versed with ICMED Schemes and Med Dev QMS.
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