MDR Transition for US Companies
Get the MDR support you need, from a team of experts who understand your ambitious business goals
Ask the Experts, not Search Engines
What MDR challenge are you dealing with?
New MDR expectations & tight timelines require companies to be more proactive than ever
According to the new MDR Regulation, all medical devices must obtain CE mark by undergoing a new and complete Conformity Assessment by May 2024.
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In-depth understanding of the transitional provisions
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Determining strategic options that articulate well with the business objectives
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A roadmap tailored to specific devices and their related Technical Documentation challenges
Run the MDR Marathon with Medidee/Veranex
Our team focuses on increasing the coherence and dependability of all the dimensions considered for your submission, with a business-oriented view.
Fabrinal has been supported closely for almost 10 years by Medidee. For an SME of our size, this change is so critical from a timing and economic point of view, that it is crucial to be advised by rational and experienced experts. I am extremely confident about their advice and application of the MDR and can navigate through this challenging change a bit less worried."
CEO of Fabrinal
