19 - 23 June 2017
Achieve successful EU MDR & IVDR implementation through direct access to competent authorities, notified bodies and industry
Including clinical strategies, PMS & vigilance, legal, combination products, companion diagnostics, and emerging markets requirements
Benchmark with experts across 8 key Medical Device and IVD areas...
EU Medical Device Regulation PLUS EU Medical Device Law
- Implementing the new MDR: Regulator, Notified Body and industry perspectives
- How can you set up a successful transition plan under the new MDR?
- Sharing thoughts and concerns on the Notified Body re-designation process
- How will the MDSAP program impact industry?
EU Medical Device Law Focus Day
- Examining new liability rules under the MDR
- Transitioning to an implementation plan: gap analysis and resource
- Assessing the legal obligations of manufacturers, importers and distributors
IVD Regulatory & Strategic Forum PLUS Companion Diagnostics
- Implementing the IVDR – Regulator, Notified Body and industry perspectives
- The new classification system for IVDs: what does this mean for industry?
- Demonstrating conformity with safety and performance requirements for clinical evidence and legacy products
Companion Diagnostics Focus Day
- What are the implications for CDx under the new EU IVDR?
- Ensuring optimal partnerships between diagnostic and pharma companies
Post Market Surveillance & Vigilance
- Compiling PMS plans and meeting requirements of the new MDR
- Ensuring best practice for Field Safety Corrective Action (FSCA) reporting
- How should Post Market Clinical Follow-Up (PMCF) activities be implemented?
- Complying with regulatory requirements for trend reporting
- What are the new timelines for post-market reporting?
Clinical Evaluations & Investigations for Medical Devices
- Clinical investigation applications under the new MDR - Regulatory perspective
- What are the new clinical evidence requirements for class III devices?
- Understanding MEDDEV 2.7.1 Rev 4: Regulator and industry discussions
- How should you implement a successful clinical investigation strategy?
- Exploring patient recruitment - from study design to execution
Medical Device Regulatory Affairs in Emerging Markets
- Accessing the exemption list and achieving compliance in Chinese clinical trials
- What are the current and upcoming plans for dossier designs in the ASEAN region?
- INMETRO Ordinance 54/2016 in Brazil for electro medical devices
- How can you navigate the approval requirements in Saudi Arabia?
Examining Russian clinical trial requirements and expectations
Drug Device Combination Products
- What are the implications for combination products under the new EU MDR?
- FDA latest regulatory updates and requirements
- How can you operate in a heterogeneous global regulatory environment?
- Reviewing the newly introduced Rule 21 on classification of substance-based devices
- Implementing human factors testing and "user centric designs"
MedTech Summit Agenda Breakdown
To find out more about the individual event tracks, take a look at the online agenda and select the days of interest...
Plan your regulatory compliance strategy with the industry's leading experts...
300+ industry experts preparing for the new MDR and IVDR
The expected impact of the EU MDR according to key-opinion leader Gert Bos
Free On-Demand Webinar
What will the webinar cover?
- 10 most critical changes
- Key impact for manufacturers
- Practical approach on hot issues (clinical evaluation, OBL)
- Notified Body situation, risks and precautions
- Tools for help with the impact of the MDR
Led by: Dr.Ir. Gert Bos, Executive Director and Partner, Qserve Group
Sponsorship and exhibition opportunities
Promote new and existing products and services to our high level delegation
Here's what some of our exhibitors had to say...
“Good conference with excellent speakers and good scientific content”
- Link Medical
“Good conference, excellent networking and great atmosphere”
- Gert Bos, Qserve
“High quality conference with well recognized speakers and a reasonable number of international attendees.”
- TÜV SÜD Product Service GmbH
"Excellent conference, very good speakers and as a sponsor and exhibitor, we had great visibility on the agenda and at the event"
- OSMUNDA Medical Device Service Group
Evening networking at the MedTech Summit 2016
A very big thank you to everyone who attended the 2016 event; it was great seeing so many familiar faces, as well as meeting lots of new ones. Relive the evening drinks in our video snippet, or if you couldn’t make it, see what you missed out on and hopefully we’ll see you next year.
Medical Device Training International | MDTI
MDTI is a global interactive training partner committed to the personal progression of Medtech professionals. We deliver CPD certified training on a wide range of topics including clinical evaluations, clinical investigations, regulatory affairs, combination products, PMS and vigilance, In Vitro Diagnostics (IVD)and soft skills. Our courses are delivered in a variety of formats such as public face-to-face, customised in-house, webinars, eBooks and online academies.