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Regulatory Consulting: Internal Audits of the QMS

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: e19505ba-883c-4170-b53a-68a4f5ba5f37

Service Description

The IPN team conducts thorough audits of Quality Management Systems (QMS) to ensure compliance with key regulatory requirements, including ISO 13485, FDA’s 21 CFR Part 820, and the European MDR and IVDR regulations. Independent auditors perform on-site or remote assessments to evaluate the effectiveness and conformity of the QMS, supporting both initial certification audits and ongoing surveillance or recertification audits.

Keywords: traceability audit QMS
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

Service Standards
  • ISO 13485
  • MDR EU 2017/745