Medical Devices

Unannounced audits

The European Commission Recommendation on audits and assessments performed by notified bodies in the field of medical devices was published on September 24th 2013.

Medical device courses 2014

Presafe Denmark A/S provides courses for the medical device industry. You can sign up for our courses in 2014 by clicking here

IAF MD 9:2011 and the Impact on Audit Duration for Medical Device Manufacturers

The International Accreditation Forum (IAF) has issued a new Mandatory Document for the Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485), the IAF MD 9:2011.