Explore the MDR's updates enhancing patient safety and understand its revised requirements and processes to navigate the evolving regulatory environment effectively.
This course is crucial for professionals already versed in medical device regulatory affairs, offering indispensable guidance on transitioning products from the current Medical Device Directive (MDD) framework to the new Medical Device Regulation (MDR).
Emphasizing regulatory strategy and lifecycle management, the program includes in-depth sessions on regulatory pathways, technical documentation, clinical evaluations, and investigations. Participants will also delve into requirements for the vigilance system, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) studies.
Through interactive case studies and practical workshops, delegates will solidify their knowledge and engage in discussions with two experienced medical device experts, navigating the complexities of regulatory compliance effectively.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
Ms Theresa Jeary,
Technical Manager for Medical Devices ,
Lloyds Register Quality Assurance (LRQA)Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.
Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been a part of the team for many commercially available medicinal and medical device products.
Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.
Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the “fence” and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).
Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.
At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.
Who Should Attend
This course will provide experienced medical device professionals with the practical regulatory knowledge to apply life cycle management in an MDR environment, particularly those who play a key role in transitioning their products to the MDR, including:
- Medical device regulatory affairs professionals
- Vigilance and PMS managers
- Clinical evaluation/investigation specialists
- Project managers
