Agenda

All times displayed for Europe/Berlin timezone.

Regulatory

Medtec Insights Theatre | Regulatory I | Hall 1
11:30 - 13:00 Location: Stand 1D51, Hall 1
Presentation
Senior Manager – Swiss Consulting
Deloitte
Senior Director IVD
Anteris Medical
Europe Manager
Namsa
Director – Risk Advisory
Deloitte

Regulatory changes and updates are an ongoing industry concern; in these two modules dedicated to the latest regulatory updates, you will gain an overview and understanding of how to reach compliance.

Module Chair: Faraj F. Abdelnour, Director, AB Certification
 

10:30-11:00
Preparing for the Future: The New EU Medical Device Regulations

  • Overview of the new EU Medical Device Regulations and its impact on the industry
  • Strategy and implementation approach for EU MDR
  • Key focus areas for consideration including: Financial implications, Programme management, Notified bodies, Supply chain, Labelling, Quality management system and Clinical evidence
  • Looking at building value beyond compliance as it applies to EU MDR

Fiona Maini, MSc BSc, Director, Risk Advisory, Life Sciences, Deloitte LLP
Martin Blanke, Senior Manager – Swiss Consulting, Deloitte

 

11:00-11:30
How to support the Implementation of the In Vitro Diagnostic Device Regulation (IVDR) by a Quality Management Software Tool
-
An overview of the IVDR regulation which is expected in the second quarter of 2017
- A risk-based approach for classification of IVD medical devices in combination with increased intervention of Notified Bodies
- Looking at the IVDR requirements for significantly more robust technical documentation.
- A quality management software tool covering requirements management and risk management helps to cover and organize all documentation necessary to fulfil the essential requirements by ensuring full traceability and the creation of reports for the technical file and design history file.
Bernd Krämer, Senior Director IVD, Anteris Medical

 

11:30-12:00
Consequences of the new MEDDEV 2.7/1 Rev 4 on clinical evaluation for legal manufacturers in the EU

- Key elements of the new MEDDEV 2.7/1 Rev 4
- Consequences for medical devices manufacturers
- Application of the new MEDDEV 2.7/1 Rev 4 by notified bodies
Vincent Legay, Manager Europe, Namsa

Medtec Insights Theatre | Regulatory II | Hall 1
13:30 - 15:30 Location: Stand 1D51, Hall 1
Presentation
Business Manager, Software and Vision
FOBA
Vice President
Unique Device Identification Solutions and Services at USDM Life Sciences
Research Director
Do UX GmbH
Biocompatibility Specialist
Nelson Laboratories

Regulatory changes and updates are an ongoing industry concern; in these two modules dedicated to the latest regulatory updates, you will gain an overview and understanding of how to reach compliance.


12:30-13:00
Usability and User Experience in medical device development

- Norms for usability in the development of medical devices: ISO DIN EN 6236662
- Avoiding risk, reducing costs and accelerating time to market through implementing a user-centric design process
-How to apply these principles to your own design & development process
Arnd Engeln, Research Director, Do UX GmbH 

 

13:00-13:30
Recent updates and changes to the most recent ISO standard on biocompatibility

• We will cover the new changes to the ISO 10993 series of standards including 10993-1, -17, and -18.
• We will highlight the impactful information for the recent FDA guidance on biocompatibility and the effect it has on your devices.
• What is on the horizon? Description on what biocompatibility will look like in the future.
Thor Rollins, Biocompatibility Specialist, Nelson Laboratories

 

13:30-14:00 
UDI Marking for Medical Devices: Challenges and Solutions

-The UDI marking content and physical limitations
- Material marking UDI challenges, metals, plastics
-The mark quality and traceability requirements
- How UDI marking reduces liability while increasing yields
Faycal Benayad-Cherif, Business Manager, Software and Vision, FOBA 

 

14:00-14:30
The US and EU UDI requirements – similarities, differences and implementation issue
The first significant changes to the medical device regulations in the European Union (EU) in over 25 years are set to finalize this year.  Among the many changes is the introduction of a UDI System for all medical devices. 
- The EU UDI System specifically (and prospectively) incorporates UDI into various new company and product registration systems and processes.  The new regulations also impose obligations for the verification and use of UDI by importers, distributors, authorized representatives and, for certain device types, healthcare providers.  The EU UDI System, though similar to the US UDI System, has some signific
Jay Crowley, Vice President, USDM Life Sciences

2017 Start-Up Presentations

Start-Up Forum | 2017 Start-Up Presentations Day 3 | Hall 1
11:30 - 15:00 Location: Stand 1I61, Hall 1
Presentation

Hear from our shortlisted start-ups on the latest innovations and learn more about opportunities for partnering and collaboration.

10:30-10:35 Welcome from the Chair

10:35 - 10:50 Desino

10:50 -11:05 StimOS

11:05 - 11:20 UBT SRL, Gianluigi Tiberi

11:20 – 11:35 NASCIENT SYSTEMS Ltd.

11:35 – 12:00 Q&A with all presenters

VDMA Exhibitor Forum

Sponsored by:

Bulk Counting Technology for Medical Components
11:30 - 12:00 3D28
Presentation
DATA Detection Technologies
Cleaning Validation with regards to regulatory expectations of FDA
12:00 - 12:30 3D28
Presentation
Customized medical plastic systems
12:30 - 13:00 3D28
Presentation
TBD
13:00 - 13:30 3D28
Presentation
Implementation of the EU-Medical Device Regulation (MDR)
14:30 - 15:00 3D28
Presentation
Technische Regelsetzung für die Medizintechnik
15:00 - 15:30 3D28
Presentation
Reconstructed Human Epidermis (RhE) model as an in vitro skin irritation test for medical devices
15:30 - 16:00 3D28
Presentation

eHealth Hub

Start-Up Forum | eHealth Hub | Hall 1
13:30 - 15:00 Location: Stand 1I61, Hall 1
Workshop

The eHealth Hub is a cross-border, newly EU-funded initiative. It will provide business oriented services tailored to the needs of European eHealth SMEs and relevant stakeholders (investors, demand side stakeholders, commercial distributors, legal and regulatory firms and experts)

In this module, a group of the most innovative new companies working in eHealth will pitch to a board of key stakeholders in front of a live audience, followed by a Q&A session.

This session offers an opportunity to understand where new innovations are coming from in the eHealth space, and what it will take to establish a route to market.