The Oregon Bioscience Association is offering a 2 day course on Internal Auditing to ISO 9001 & ISO 13485. This is perfect for any Medical Device Company that needs to set-up an internal audit program to meet the requirements of
EC publishes draft regulation on electronic IFUs of Medical Devices
24 June 2011 – From Eucomed e-newsletter – European Commission publishes draft regulation on electronic instructions for use (IFU) of medical devices. ‘Stakeholders can send their comments by 8 August 2011. The Eucomed Alternative Labeling Task Force will meet on 1 July
EU EN IEC60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity
Do you have EU transition period questions related to the MDD & AIMDD Harmonized Standard EN IEC 60601-1:2006 (or sometimes known as 3rd edition of EN IEC 60601-1), its’ collaterals (EN IEC60601-1-XX) and its’ particulars (EN IEC 60601-2-XX) standards? If
FDA Draft Guidance – Human Factors & Usability Engineering
The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Industry and FDA Staff as of June 22, 2011. A 90 day comment period is
ISO 13485 Revision – User Requirements Survey
On LinkedIn there is a survey posted to find out what users of the standard ISO 13485 think about revising the standard. “The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003