This practical 2-day introductory-level training course will examine the complex processes involved in meeting the EU regulatory requirements associated with Medical Devices.
The European Commission are currently undertaking a further complete Revision (Recast) of the regulatory requirements. Learn about these proposals and the latest developments and how these will affect you in the future.
From early decisions regarding the most appropriate conformance route of a product, through to post marketing adverse event reporting, 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 experience within the industry, Anne has set up her own consulting company as an advisor on regulatory affairs and quality assurance to medical technology industries. Before setting up her own company, Anne worked for TUV Product Service Ltd, 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 Certifi cation 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.