Eamonn Hoxey, BSI Group The Medical Device Single Audit Program–MDSAP–was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of quality management systems (QMS). Health Canada’s decision to require an MDSAP audit to maintain Canadian Device Licenses is leading to a rapid increase in use of the program. There is a […]
BSI Group
What is the future of harmonized standards?
Nele Zgavc, BSI Group For national standards bodies, 2018 brings a big challenge as we aim to generate appropriate revisions of key standards that manufacturers use to show compliance to essential requirements. These harmonized standards include an Annex ZA/ZZ which represents the correlation between the requirements in the EU Medical Devices Directives (MDD, AIMD, IVDD) […]