We recently updated our website to make it easier for you to check the current IEC 60601 standards and the test report forms (TRFs) and you can check the status of draft standards and where in the process they are.
Medical Device Audit Training Opportunities
Rob Packard & Brigid Glass have a couple opportunities for you to learn about different aspects of medical device auditing. These offerings are in February & April 2013 and range from a 1 hour audio conference, to a free webinar,
Internal Auditor Training on ISO 9001/13485 JUL 12/19 ’11 PDX area
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
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
How Comment on FDA CDRH FY11 Draft Guidance Documents?
How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents