MEDICAL COMPLIANCE SEMINAR Thursday, May 18, 2017 Seminar Topics: Current guidance around Medical Electrical Equipment for FDA 510(k)s & Health Canada IEC 60601-1 series: Intro to IEC 60601 -1 series with Collateral & Particular Standards Design & compliance to IEC 60601-1
UK MHRA Guidance on EU Regulation 207/2012 on electronic labeling of med dvcs
On 9 Jan 2013 the UK MHRA (The Medicines and Healthcare products Regulatory Agency) released a Guidance on EU Commission Regulation 207/2012 on electronic labeling of medical devices. This regualtion came into force on 1 March 2013 so you can
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