BSI recently updated the white paper on Proposed EU Regulations for Medical Devices & IVD’s to reflect the latest EU vote in early April, enabling the commission to move forward with the legislation.
Refer to the previous blog post on BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s for additional details about the white paper and the Series of white papers.
You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website).
If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at , or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).