"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Creating a successful clinical strategy for your medical device - Do’s and Dont’s
This tailor-made training gives you the tools to create a successful clinical strategy for your medical device.
The course covers the core elements of MEDDEV 2.7/1 Rev4, ISO 14155:2011, Council Directive 93/42/EEC (MDD), and Regulation (EU) 2017/745 (MDR). Selected aspects on how to maximize the use of clinical data between the EU/US will be covered.
The clinical strategy principles covered in this course are based on MEDDEV 2.7/1 Rev4, the international recognized standard ISO 14155:2011, the MDD, and MDR. The content is tailor-made for the medical device industry with strong focus on how to create a successful clinical strategy for a medical device and maximizing the impact of regulatory and clinical aspects.
After completion of the course you will have the understanding of how to create a clinical strategy based on the clinical evaluation, clinical investigation, post-market surveillance and post-market clinical follow-up.
- Clinical Evaluation according to MEDDEV 2.7/1 Rev4
- How to determine whether or not a clinical investigation is required
- The equivalence approach – possibilities and limitations
- How to establish, maintain and update clinical evaluation documentation throughout the product lifecycle
- Clinical Investigation according to ISO 14155:2011
- Practical guide to the requirements of a clinical investigation on medical devices
- Step-by-step: How to execute a clinical investigation
- How to maximize the global value of a clinical investigation
- Changing regulations and how it can affect your clinical investigation
- Usability aspects in clinical investigations
- Post Market Surveillance and Post Market Clinical Follow up
- Practical guidance to fulfil the lifecycle concepts in the MDR
- What, when, and how - strategies depending on device classification
On completion of this training, participants will be able to:
- Understand requirements and impacts on clinical strategy of the new MDR and how they may impact your clinical strategy
- Understanding of the preparation of a Clinical Evaluation in accordance with MEDDEV 2.7/1 Rev 4
- Maintain and update Clinical Evaluation documentation throughout the post-market product lifecycle
- Determine whether or not a clinical investigation is required
- Understand the role of clinical investigations in the development of medical devices
- Understand the basic requirements on how clinical investigations are carried out
Who should attend:
- Medical device manufacturers, especially if your role is in:
- Regulatory Affairs
- Design and Development
- Clinical Affairs Specialists
- Quality Management
- Quality Assurance
- Medical Device Consultants
Prerequisites (Previous Knowledge)
At least one year of professional experience within the medical device industry and basic knowledge about regulatory requirements within the field.
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9.00-17.00 (Registration 08.30-09.00 day 1)
Price (excl. local VAT):
Register by 15 Oct - Save 1 500 DKK
Until 15 Oct 13 750 DKK (€ 1850)
From 16 Oct: 15 750 DKK (€ 2050)
Incl. course material (pdf), lunch and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.