FREE IVDR CHECK-UP
Have your IVDR readiness assessed free of charge by experts in the field.
"IVDR SUBMISSIONS LARGELY INCOMPLETE"
If you are the legal manufacturer of a new or existing IVD product, you may be asking yourself, "Is my product's technical documentation complete and compliant with the requirements of the new EU IVD Regulation?"
The European Commission recently reported that most applications for IVDR conformity assessment are judged by notified bodies to be largely incomplete. The same observations were made by the Veranex team.
-> Are you planning to place an IVD device on the EU market?
-> Will your legacy device undergo a conformity assessment under the new regulation?
We propose to have your IVDR readiness assessed free of charge.
As part of this activity, Veranex will assess which documents require major updates prior to notified body submission.
To participate in this event, you should follow these steps:
- Book a free slot in the calendar
- Sign our Confidential Disclosure Agreement;
- Share the documentation required within 3 days.
Detailed information and instructions will be sent to you by e-mail once you’ve registered. In case the documentation required is not sent within 3 days after you've received our Confidential Disclosure Agreement, your registration will be cancelled and the slot made available to another participant.
Register now for an exclusive and complimentary video conference session.
During this 1-hour session, our experts will provide feedback on the specific sections of your technical documentation that, based on our experience, are more likely to present significant deficiencies:
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Device description
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IFU
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History of change
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GSPR checklist
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Risk Management File
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PEP/PER
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Usability Engineering File
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PMS/PMPF plan
By knowing your gaps in advance, you will be able to address them before submitting the technical documentation to your notified body, thus facilitating the conformity assessment procedure under IVDR.
ABOUT VERANEX
Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry.
Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process.
Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care. Our team of qualified IVD specialists have extensive experience in communicating with notified bodies, helping our IVD customers find the most effective strategy to access their target markets.