EARLY JULY 2021 AAMS OBTAINS renewal of ITS ISO 13 485 CERTIFICATION.
NEW DIRECTIVE, NEW REGULATION, NEW CERTIFICATION
Audited by the GMED in early July, AAMS/BFP Research has reached a new milestone in terms of medical device quality with the renewal of its ISO 13 485 certification and of our medical CE certificates until march 2024, in transition to MDR 2017 / 745.
Indeed, this stricter European regulation allows a better monitoring and follow-up of medical devices in order to limit the potential risks for patients.
As expected, AAMS responded positively to this new challenge through its work and efforts.