Medical Device School - A 3-day training course
The Medical Device School by MDTI offers delegates the opportunity to gain insight on the medical device product life-cycle, from research and development to regulatory approval and market entry. In an interactive format, delegates will meet with industry professionals, share experiences and participate in collaborative learning.
This course will be broken into 5 core sessions covering classification, risk management, biocompatibility, vigilance and reimbursement. Special attention will be placed on the role of European industry associations in device regulation, relevant legislation, U.S. medical device regulations, risk management strategies, drug device combination products and the development of clinical strategies.
Suitability - Who should attend?
This training course is is ideally suited to pharmaceutical professionals wishing to improve and expand their knowledge of the medical devices industry. This course is appropriate for professionals of all levels of experience, including those who are currently employed, graduated, newly employed or are pursuing career advancement.
Training Course Content
This training course will include the following modules:
- The latest advancements in the Medical Device Directive and how it can affect products
- Clinical data requirements
- Specific timelines for implementations
- Risk management strategy
- Key advice on developing an appropriate risk management plan
- The legal side of developing medical devices
- Developing a strong patenting strategy
- Howe patent systems differ in in the US and Europe
- Labelling requirements and sterilisation of medical device products
- Meeting regulatory requirements in early research and developing
- Re-active vs. pro-active
- Benefits of moving towards pro-active compliancy with post-market surveillance regulations
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
Average rating 4.8
Eye opener in regards to some of the challenges connected to medical devices in the 21st century.
The course was very applicable. Presenters were very knowledgeable and presented their sections professionally and met the objectives. I would recommend it!
Very good introduction to medical devices.
PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.