The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU. You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF. With the exception of
FDA Issues Draft Guidance doc on Mobile “App’s”
On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”.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 (See details on web link for draft guidance). The draft guidance document states in section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