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Regulatory Consulting: Person Responsible for Regulatory Compliance

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 000845b3-a8db-4207-b6db-7e1e2ee68da9

Service Description

According to Article 15 of the MDR, the manufacturer of medical devices is required to have, within its organization (or an external person for small companies), a person who is responsible for regulatory compliance and with the explicit responsibility to ensure that all 'Manufacturer's Obligations' are met (Article 10). Our team includes competent and experienced people to play the role of Person Responsible for Regulatory Compliance, ensuring:

  • The verification of the conformity of medical devices according to the QMS (Article 10(9), MDR);
  • Maintenance and updating of technical documentation (Article 10(4) and (6), MDR);
  • Compliance with market surveillance obligations (Article 10(10), MDR);
  • Fulfilling incident reporting obligations (Article 10(13), MDR).
Offerings: Ethics & Regulatory Affairs Quality Management Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country Portugal
Published Email medicaldevices@ipn.pt

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Certification Support CE Marking (MDR, IVDR)