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Quality & Compliance
MDR & ISO COMPLIANCE
RPN can provide full assistance to manufacturers in implementing and maintaining a Quality Management System (QMS) in accordance with the requirements of the EU Medical Devices Regulation 2017/745 and ISO 13485 standard.
RPN solutions include:
- QMS gap analysis as per the requirements of ISO 13485.
- Quality Manual development.
- Standard Operating Procedures (SOPs) and quality technical agreement development.
- Internal and supplier audits.
- Contacts with Notified Bodies.
- Support during in-company inspections carried out by Regulatory Authorities and Notified Bodies.