In late March, US FDA released a 36-page document containing frequently asked questions (FAQ) on the Medical Device Single Audit Program (MDSAP). The 96 FAQs are organized around three major areas, General, Assessment related and Audits and contain multiple links back to other documents, including the IMDRF documents. Relationships to WHO, ISO 13485, NRTL and… read more
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Medical device customers can now receive audits and certificates to ISO 13485:2016 to align with global regulatory requirements. >> Click here to view the press release version.
On February 22nd, 2017, the texts of the EU Medical Device Regulation and IVD Regulations were published. With the publication, the process for transition is now moving forward. The European Council will meet on March 7th and then the EU Parliament (ENVI) will meet March 20th . Following that the Parliament meets in April and… read more