With the expected publication of the Medical Device Regulation in 2017, the medical device industry is now undergoing a great deal of change. This flexible online course offers students an excellent opportunity to understand the entire medical device product lifecycle in the context of these pending updates.
This course will allow you to engage with and learn from a range of leading experts in the field and come to grips with regulatory affairs, quality management systems, risk assessments, clinical evidence requirements and commercial aspects of medical devices.
The new MDR will necessitate a degree of transformation to the medical devices industry, including changes to classification and essential requirements for proving compliance, among others. Designed for those new to medical devices, or needing a broad overview, this course will cover a variety of major topics to give an excellent understanding of the area.
• Introduction to the new Medical Devices Regulation
• Classification for medical devices
• General safety and performance requirements
• Technical documentation
• Understanding conformity assessment routes
• Performing a risk assessment
• Preparation and strategy for audits
• Overview of vigilance requirements
• Changing roles for economic operators
• Introduction to Clinical Evaluations
• Understanding Clinical Investigations
Mika has a Master’s degree in Law from the University of Nice and later gained a Master’s in Business Administration from the Wharton School.
He has more than 30 years of experience managing European medical regulatory affairs in industry, as a healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives and of technical standards since the 1990s.
He founded the medical device consulting company Abnovo Ltd in 2007 to provide a wide variety of networked services to the medical device industry worldwide.
He is currently a member of various medical device expert working groups of the European Commission and is Chairman of the European Association of Authorised Representatives (EAAR).
Anne has her own consulting company, advising on regulatory affairs and quality assurance to medical technology industries. Anne previously 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. In addition, Anne worked for TUV, where she was responsible for the development of the Medical-Health-Sports (MHS) Business Unit.
Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. He has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical.
Richard has held various positions within industry such as QA/RA Manager and Director Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.
Victoria Cavendish is a highly skilled Clinical Affairs specialist with a solid understanding of the associated Quality and Regulatory landscape gained over 15 years within academia, medical device manufacturing companies, and Clinical Research Organisations. Victoria has held senior positions at various medical device companies such as Premier Research, Reckitt Benckiser and Novartis Pharma AG managing successful clinical teams.
This course is designed for all professionals wishing to improve their knowledge of the medical devices arena, whether you are new to this or currently work in a related area, or would benefit for your future career development.
Professionals already experienced in the medical devices industry may also benefit from the course as an introduction to the new Medical Devices Regulation.
MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
The modules were clear and concise and allowed me to get a much better understanding of the Medical device world as well as the MDR.
Once you have registered and made the full payment, you will be given login details to access the course.