Compliance with the Medical Device Regulation (EU) 2017/745 (MDR) presents many new challenges to medical device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges in order to smoothly bring your device to market under Medical Device Regulation (EU) 2017/745 (MDR).
Learn how to interpret and navigate the regulations, determine device classification and understand device conformity assessment routes. The course will address the enhanced requirements under the Regulation, General Safety and Performance Requirements (GSPRs), and clinical evidence, post market surveillance, including periodic safety update reports and vigilance.
As well as looking into the role of competent authorities and notified bodies, the course covers the requirements to keep your device compliant under the existing Medical Device Directive (whilst your CE Certificate remains valid).
The course features interactive workshops, including an in-depth look at ISO 13485, providing the opportunity for one-to-one discussion with the course tutor during the break-out sessions. To cater the training further, all delegates will complete a gap analysis exercise, allowing you to review your current products and assess compliance against the new legislation.
Interested in Medical Device Regulatory training for your team? Contact us today.
The course is intended for individuals that work for a Medical Device manufacturer or CMO who hold responsibilities that require them to understand Medical Device Regulation (EU) 2017/745 and the differences/issues from the current MDD. In particular, Quality Management, Quality Assurance, regulatory affairs, design and development, clinical affairs specialists, authorised representatives, economic operators (including importers and distributors) may find this course beneficial.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community