On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”. There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance). The draft guidance document states in section
Health Canada Final Guidance – Reprocessing & Sterilization:Reusable Med Dvcs
On June 1, 2011 Health Canada issued a notice releasing the final guidance on ‘Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices.’ The following text has been taken straight from the Health Canada
E-Submissions Coming for Med Dvc & Pharma Mfrs
From AAMI News: July 2011: E-Submissions Coming for Medical Device & Pharmaceutical Manufacturers http://ht.ly/5y1ZQ
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
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