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Darapy Medtech Consulting

DARAPY MedTech Consulting is a consulting company specialized in IVDs. We provide a wide range of services in Product Development (Immuno and Molecular Diagnostics), Regulatory Affairs, Performance Evaluation studies and Quality Assurance services from early-stage to well-established In Vitro Diagnostic (IVD) products. With Scientific, Regulatory and Quality experience and understanding of any type of IVD product: Instruments, Softwares, Reagents, Kits, controls, etc...
ABOUT

Services

Our services for medical devices IVD include:

Performance evaluation

Post-market surveillance

Vigilance

Clinical Evidence

Analytical performance

State-of-the-art

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Literature Search

Technical file

Quality Management System

Risk Management system

Product registration

PRRC

SERVICES

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News

Post-MDCG-2020-16-rev.2

Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲

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DARAPY MedTech Consulting is a consulting company specialized in IVDs. We provide a wide range of services in Product Development (Immuno and Molecular Diagnostics), Regulatory Affairs, Performance Evaluation studies and Quality Assurance services from early-stage to well-established In Vitro Diagnostic (IVD) products.
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