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Regulatory Consulting: Regulatory Roadmap/ Technical Documentation Gap Analysis

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 70c5529a-da16-40ae-ac49-780d31e3a803

Service Description

IPN performs gap analysis, in order to assist the success of MD or IVD development projects, with the ultimate goal of making the devices available in the intended markets. This analysis identifies data gaps in projects, procedures, and product regulatory roadmaps, considering the regulatory requirements. The regulatory/market assessment gap analysis consists, among others, of the following steps: map out current policies and procedures; outline the regulatory and normative framework and determine which requirements the organization and/or project needs to meet; identify and analyze the gaps; establish concrete recommendations on how to resolve the gaps.

Keywords: MDR Gap Analyses IVDR
Offerings: Technological Solutions & Documentation 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- Device description and general information. 2- Existing test reports (according to mandatory applicable standards) 3- raw material technical information (if applicable)
Service Outputs Execution report
Certification Support CE Marking (MDR, IVDR)