EUMDR introduces new requirements for the medical devices manufacturers, which explains the Roles of PRRC. according to the new regulation of EUMDR, which came into force on 26 May 2021 the medical device manufacturer should have a PRRC to keep an eye on regulatory compliance. PRRC’s plays vital roles and responsibilities in setting up the plants for manufacturing medical devices.
The PRRC’s are the authorized person who should have some specific qualification and experience .EU has published new rules and regulations for medical devices manufacturers that, these companies or organizations should have PRRC with them to look out the matter of regulations and policies PRRC is responsible for regulatory compliance Article 15(1) of MDR and IVDR has outlined some specific prerequisite for PRRC.
The medical device manufacturer who wishes to sell/ supply their device in European Union they must have at least one Person Responsible for Regulatory Compliance (PRRC) at their site of disposal.
- Who can be PRRC and what are their Roles and responsibilities?
- What are the Roles of PRRC and Responsibilities of PRRC?
- Is that authorised representative requires PRRC?
Contact details –
Phone no - 9325283428Mail - dm@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.\- Medical Device Consulting
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- 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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