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Regulatory Consulting: Risk Evaluation Gap Analysis

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 902fd7da-5549-4e09-ab98-f85b7c9cf0b5

Service Description

Risk evaluation gap analyses are designed to assess the potential risks and vulnerabilities associated with medical devices or IVDs. The IPN team assists companies by conducting comprehensive gap analyses of current risk identification and evaluation processes for their devices, identifying any shortcomings in the existing risk management framework. Leveraging the principles outlined in ISO 14971, the team evaluates the adequacy of risk management practices and ensures compliance with international standards. Based on this initial evaluation, the team can also support the development of an action plan to mitigate or eliminate identified risks effectively.

Offerings: Ethics & Regulatory Affairs Business (market readiness, monitoring, feasibility, etc.) 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 Inputs 1- Risk management file
Service Outputs Gap Report
Certification Support CE Marking (MDR, IVDR)