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Hello EVERYONE!

For Medical Device Clinical Evaluation, we have the talents with cross-platform expertise and in-depth knowledge in MDR Article 61 & Meddev 2.7/1 Rev.4, to start a project right away!

Trying to do it in-house could involve employee hiring, training, and providing the support they need, all of which will cost your time, money and finally no assurance of success.

MEDDEV 2.7/1 Rev.4 is the guideline that will guide you to conduct Clinical Evaluation of your device!

The MDR regulation has brought about significant changes in the CER compared to the previous Directive

A comprehensive and systematic literature search will ensure ample clinical data to meet the EU MDR GSPR

Meddev 2.7/1 Rev. 4 CER gap analysis will help you identify where you need further support in the CER!

Post Market Surveillance (PMS) will help you keep a check on your device after it has been placed on the market!

PMCF confirms the clinical performance & safety of device, ensuring the acceptability of the residual risks.

Manufacturers of Class IIa and above are obliged to submit a PSUR as per Article 86 of the MDR

Brainstorming Interactive Ideas on MDR Article 61!

EU MDR article 61 clinical evaluation reports and present convincing interpretations to justify clinical safety and performance of the device with in-depth supporting documentary evidence . I3CGLOBAL will reduce significantly loss of revenue from manpower and decreases time to market.

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Our Story

Manufacturers Challenges

Here are a few challenges that we have heard from the medical device manufacturers

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EU Representative
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New MDR Classification

Clinical testing requirement for products earlier exempted, Interpretation of scientific Clinical data, availability & readiness of CER throughout the year

PMCF & PSUR Compliance Monitoring

Keeping track of annual safety updates and maintaining dynamic data records

Establishing "State of the Art"

Establishing state of the art (SOTA) with an extensive amount of supporting clinical data, the outcome of benefit-risk analysis and results of applicable bench testing

We are a Bunch of Regulatory Professionals & Clinical Writers

We solve every obstacle in the path of MDR Article 61 and Meddev 2.7/1 Rev. 4 compliance.

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CER Writing Fees

Experience matters! Clinical writing should be made in a convincing and justifiable way to get approval.

PMS Writing Fees

We do things with the assurance and approval from Notified Bodies. Low cost doesn't mean the quality is bypassed.

Documents for Sale!

World's first company to release a complete set of editable procedures and templates for sale!!

End-to-end solutions for small, medium and large scale medical device manufacturers

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