MedPass is ISO 13485:2016 certified !

Our Quality System is an important part of the services that we provide our clients. Therefore we are happy to announce TÜV Rheinland has recertified MedPass for the latest version of ISO 13485. ...

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ICON Acquires MedPass International

ICON plc, (NASDAQ: ICLR) a global provider of drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device industries, today announced that it has ...

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Webinar: Navigating the “new normal” during COVID-19: A regulatory and clinical perspective for medical devices

Due to COVID-19, regulatory agencies are relaxing guidelines and shifting priorities to address shortages in diagnostics and respiratory devices. For more information on this webinar and to join, ...

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MDR – Proposed delay for one year

Last Friday, 17 April 2020, the European Parliament adopted the proposal from the European Commission by urgent procedure (with 693  votes in favor, 1 against and 2 abstentions) allowing the ...

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MedPass business continuity plan during the COVID-19 health crisis

As the COVID-19 crisis evolves we are taking additional security measures to protect our employees and clients. We have established a business continuity team (BCteam) who are implementing a ...

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Revision of ISO 14155 – Good clinical practice

The third edition of ISO 14155 is currently being prepared for circulation and ballot as ISO/FDIS 14155:2019.  Jeremy Tinkler, Director of Regulatory Consultancy at MedPass and Chairman of the ...

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BREXIT: MedPass can act as UK Responsible Person in the UK.

The MHRA has just announced that in the event of a no-deal Brexit all medical devices must be registered with MHRA prior to being placed on the UK market. If the manufacturer is based outside the ...

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What happens to your Medical Devices in case of NO Brexit deal?

MedPass can help you with Medical Device Registration in the UK in case of no Brexit deal. On 4th January 2019 the MHRA (the English Competent Authority) published a guidance note, to provide ...

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EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

  Interview by Amanda Maxwell The EU’s new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. What ...

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GDPR at MedPass International

For MedPass International, data protection and privacy is critical to our business and a priority for our organization. Our commitment to handling data meticulously and respecting privacy is core ...

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