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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
Provider Logo

Provider & Contact

Provider Organisation Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
Provider Country Portugal
Published Email medicaldevices@ipn.pt
Billing: per hour
Full Price €85-150 EUR
Reduced Price €0-120 EUR
Pricing Detail

depending on seniority

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)

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