Implementing and maintaining a strong quality management system (QMS) for your medical devices, products, and services is critical to the success of your company. Your QMS’s EN ISO 13485 certification displays your dedication to working at a worldwide level. As ISO 13485 medical device consultant we assist our clients in creation of documents for the ISO 13485 certification. On-site audits are part of the EN ISO 13485 certification process and they assess your quality management system’s competence and reliability. In the areas of design, development, production, and customer service, our professionals examine both the practical implementation and the degree of effectiveness.
Amendment
In September 2021, a revision to EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes – was released. The European Foreword, as well as Annexes ZA, ZB, and ZC, are all replaced by this revision. The relationship between the clauses of the standard and the requirements of the three European Directives for medical devices – the Directives for active implantable, medical devices, and in vitro diagnostics – was shown in Annexes Z from the previous edition of the standard.
These three Annex Zs have been replaced by two new Annex Zs, designated ZA and ZB, which determine the connection between the standard’s clauses and the requirements of the Medical Devices Regulation ((EU) 2017/745) (MDR) and the In vitro Diagnostic Medical Devices Regulation ((EU) 2017/746), respectively (IVDR).
Read More - Amendment to EN ISO 13485:2016
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Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
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- FDA 510k Clearance
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- TURNKEY PROJECT CONSULTANT
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- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
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- qms certification services
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- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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