Risk management is a complex but necessary process for medical device companies, and its complexity has only heightened with the introduction of more stringent regulatory requirements under ISO 14971 and the Medical Device Regulation (MDR). It is crucial to learn how to correctly modify your approach, so that you are harmonised with the new Regulations and can guarantee your compliance.
This online course will provide you with a complete overview of the key regulatory considerations for risk accompanied by the tools and techniques you can use to implement them, for both professionals new to the area and those who need an update on the latest developments. You will be able to cement this knowledge through an entire module on case studies based off the trainer’s own experiences, so you can practically apply the information you have learned.
Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. 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
This course will be useful for personnel involved in risk assessment and risk management activities, and for those who are new to the industry and need a complete overview of the medical device regulatory framework in the EU. It will be applicable for professionals in:
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.
Once you have registered and made the full payment, you will be given login details to access the course.