Trust the experts! We provide Certified Medical Device Consulting Services since 2010. We have developed a consolidated method for achieving MDR transition smoothly.
MDR Transition Intelligence
From defining NB and align expectations, to set clinical strategy, perform all necessary tests and manage timeline to get technical documentation submission ready delivered, until responding to deficiencies up to final release of MDR certificate.
We have supported dozens of companies from start-ups to bluchips, with different products:
- from class I to class III
- from implants to electromechanical
- combination products, substance based, SaMD and innovative therapies.
We have relations and experties dealing with main notified bodies, ensuring success by defining transition strategy ahead to walk on a clear and smooth path during the process.
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Whole range of expertise in House
We have a team of seasoned experts in the different areas like:
- Clinical Evaluation, PMCF
- Post Market Surveillance, PSUR, SSCP
- Biological and Toxicological Evalution as per ISO 10993
- Risk Management as as per ISO 14971
- Usability as per IEC 62366
- Electrical Safety and EMC as per IEC 60601 series
- Software as per IEC 62304
- Process Validation and IQ/OQ/PQ
- UDI and EUDAMED
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Full EU Market Access in ONE GO
We can streamline whole Europe Market access as we can provide under one umbrella:
- Swiss Rep service with our Swiss office
- UK Rep /UKCA service with our UK Office
- EU AR service without Italian office
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EUROPE IS NOT ENOUGH!
Once your products are MDR certified, we can still support with international registrations and submissions such as for example:
- US (510k and PMA)
- Korea
- Saudi Arabia
- Australia
- Canada
- Brazil
- Japan
- China
- North Africa
- Middle East
Reach out now!
