European authorized representatives and others have recently cited an apparent lag in medical device manufacturer preparedness for the new European Medical Device Regulation 2017/745. ComplianceAcuity has always been on the cutting edge of organic compliance with European device requirements, with its Principal one of the inaugural small group of individuals in the world to achieve […]
The three-year transition period of ISO 13485:2016, “Medical Device – Quality Management Systems – Requirements for regulatory purposes” will conclude on February 28, 2019. Specifically, organizations’ ISO 13485:2003 certificates will no longer be valid as of March 1, 2019. ComplianceAcuity clients have already achieved multiple transitions to ISO 13485:2016 with ComplianceAcuity’s help and leading transitional […]
For several years ISO 13485:2003 (which is the heart of BS EN ISO 13485:2012) has been under revision. After incorporation of numerous comments and feedback from many international stakeholders, a final draft of the standard has now been released by ISO Technical Committee 210. It is expected that the final standard will be published in […]
For updates from the European Commission regarding revision of the European MDD, click the link below: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm
CDRH is now accepting web-based applications for Certificates to Foreign Government. The web-based applications are to be submitted electronically through the CDRH Export Certification Application and Tracking System (CECATS). CDRH purports that use of CECATS for CFG applications will offer several benefits, including a reduction in certificate processing time (CFG’s are projected to be issued […]
The ComplianceAcuity complaint handling solution was featured by F-D-C Reports in “The Silver Sheet” in September 2006 after the process was implemented at a large international device manufacturer during a global quality system remediation campaign spurned by an FDA warning letter.