Services
- CertificationWhatever the size of your company, wherever you are based, and whatever the category of your medical devices, we make it our mission to support you throughout your certification process.
- TrainingThe GMED North America Training Center delivers to you its expertise to enhance and develop your skills.
  - Training Catalog
  - Request a Training
- Focus on Medical DevicesTechnical and regulatory information in key medical device fields.
Company
- CompanyPresent in both Europe and North America, GMED’s level of excellence and standards have made it an internationally recognized name in the field of medical device certification.
Knowledge Center
Events

Monday, August 12th

News

Update of the MDSAP AU P0002 document – Audit Approach

An updated version (version 009) of the MDSAP Audit Approach is now available. The following changes have been made:

Update/removal of some specific Australian requirements related to the Australian Sponsor,
References to ordinance MHLW MO169, previously harmonized with ISO 13485:2003, have been expunged from the document in its entirety, considering that since March 2024, only the 2021 amendment is applicable (harmonization with ISO 13485:2016)

Content