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With the publication of the Medical Device and IVD Regulations earlier this year, as well as ongoing Brexit negotiations, this was definitely a timely...

ABHI Regulatory Conference – 2017 Update - London, 05 October 2017

October 12, 2017

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Psephos Presents - The new EU Medical Device & IVD Regulations: Strategy & Requirements Workshop

December 17, 2018

Robin Stephens from Psephos Biomedica and Jacques du Preez from Mosaic Surgical presented an EU Medical Device & IVD Regulations - Strategy & Requirements Workshop on Wednesday 12th December in London. The new EU Medical Device Regulation (MDR) is in its implementation phase and will be effective from May 2020.  All medical devices will need to comply with this new legislation.  Similarly, the IVD Regulation (IVDR) will be in force from May 2022.  Many companies are not yet ready for the journey let alone have a roadmap of how to get to compliance

 

This event provided:

  • An overview of the key areas likely to need upgrading to comply with the MDR/IVDR

  • Assistance in  assessing your company’s current preparedness for the transition

  • A clear, practical guide to the next steps that you and your company need to take to gain CE Marking under the MDR/IVDR

Participants gained:

  • An overview of the new EU Medical Device and IVD Regulations

  • An Understanding of the key areas of compliance required

  • Understanding of the technical documentation that should be in place 

  • A plan of action for implementation and CE Marking under the new legislation

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