After years of discussion the European Commission recently finalised the new Medical Devices Regulation. This 2-day introductory-level training course will examine the requirements outlined in the new Regulation as well as the existing Directive.
Major topics you will examine include classification, conformity assessment routes, post marketing adverse event reporting and labelling. Delegates will learn which regulations directly apply to their product and what steps need to be taken to achieve full compliance and ensure patient safety.
With years of industry experience, Anne has set up her own consulting company as an advisor on regulatory affairs and quality assurance to medical technology industries. Anne previously worked for TUV, where she was responsible for the development of the Medical-Health-Sports (MHS) Business Unit through quality assured operational processes, auditing and product testing of MHS products/systems. She also worked for BSI Product Certification as a Medical Devices “notified body” Certification Manager, managing BSI’s regulatory compliance for CE marking to the Active Implantable Medical Devices Directive 90/385/EEC and Medical Device Directive 93/42/ECC.