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 * Expertise
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REGULATORY AFFAIRS



Selecting the correct regulatory pathway is critical. We support you taking
control of your access to the market

Read more


CLINICAL - CRO



We help you build a sound clinical strategy to demonstrate the safety and
efficacy of your product

Read more


DATA PROTECTION



Patient data protection is currently a hot topic with the activation of the
2016/679 Regulation – GDPR

Read more


NEWS & EVENTS



Discover our next events, talks and congresses.

Read more


RESOURCES



Discover our library featuring our latest articles and videos.

Read more


TRAININGS



Agenda of the next training sessions organized by Medidee.

Read more


REGULATORY AFFAIRS



Selecting the correct regulatory pathway is critical. We support you taking
control of your access to the market

Read more


CLINICAL - CRO



We help you build a sound clinical strategy to demonstrate the safety and
efficacy of your product

Read more


DATA PROTECTION



Patient data protection is currently a hot topic with the activation of the
2016/679 Regulation – GDPR

Read more


NEWS & EVENTS



Discover our next events, talks and congresses.

Read more


RESOURCES



Discover our library featuring our latest articles and videos.

Read more


TRAININGS



Agenda of the next training sessions organized by Medidee.

Read more




MEDICAL DEVICES & IVD SERVICES



Medidee – Now a Part of Veranex –  is the #1 end-to-end consulting service
provider to the MedTech industry. Our services cover all product development
steps, from initial project idea to certification or regulatory clearance.



REGULATORY AFFAIRS



Establish a Regulatory Pathway

Program your MDR/IVDR Transition

Obtain CE mark

Prepare 510k or PMAs

CLINICAL AFFAIRS CRO



Design clinical strategy aligned with R&D

Get approval for clinical investigation

Monitor clinical investigation

Document your CER

QUALITY ASSURANCE



ISO 13485:2016

QSR – FDA

QMS architecture

Supplier controls

Internal audits

CAPA, documentation control

DIGITAL HEALTH



Support in the development of Software as a Medical Device

Software classification & validation

Cybersecurity assessment

Support with GDPR-HIPAA


AREAS OF EXPERTISE



With the diverse professional background and practical experience of our team,
we are able to provide you with the best advice, adapted to your specific
products, markets and goals.


AIMD


ACTIVE DEVICES


DIGITAL HEALTH


COMBINATION PRODUCTS


SUBSTANCE-BASED DEVICES


CATHETERS & CIRCULATION


IMPLANTABLE


IVD






READY TO GET YOUR PROJECT ACROSS THE FINISH LINE?


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