10 September 2019
Messe Luzern Horwerstrasse 87, CH-6005 Luzern Switzerland
For the fifth edition of MedBraid, we are presenting this year’s event in collaboration with Swiss Medtech Expo Luzern. The event is focused on the themes of EU’s MDR, Biocompatibility, Validation and Sterilisation of Medical Devices. Presenting the themes are industry front-runners and experts that have profound theoretical and practical insights. As well as being a networking event, MedBraid 2019 allows for you to have a one-to-one conversation with the experts.
The presentations taking place at MedBraid 2019 will be:
“Biocompatibility: Understanding the new ISO 10993”
Traditionally, the biological safety evaluation of medical devices was approached as a check list of biocompatibility tests required to meet regulatory compliance. ISO 10993:2009 shifted this paradigm by introducing a risk management process and material characterisation. This trend is continued in the 2018 version that requires manufacturers to plan biological safety testing using a risk-based approach before contracting laboratories and performing tests. We will discuss these changes and how manufacturers can address them.
“Ethylene Oxide Sterilisation: The development & validation of effective processes”
When developing a sterilisation process, we might instinctively think that the most effective process is the one with the most sterilising agent. However, this is a misconception and reflects only one aspect of the sterilisation process In this presentation we will thoroughly go through all the parameter types used during an EtO sterilisation process and will discuss how they individually affect the different aspects of a product/packaging. We will also go through practical examples and case-studies.
“Complying with the European Union’s MDR”
The European Union’s MDR date of application is 8 months ahead. For the development of new devices, most manufacturers have already shifted from the regulatory framework of the directives to the new one of the regulations. The presentation gives an overview of the current status of implementation and an outlook on the coming months until application.
“Additive Manufacturing (3D Printing) Microbiological Considerations for DePuy Synthes Resorbable Polymeric Patient Specific Implant”
3D printing of resorbable polymers presents unique sterility assurance and cost challenges, such as the microbiological risks during printing and downstream manufacturing processes and the large volume of leftover powder for each product lot produced. Thispresentation will discuss some of the microbiological risks during this complex 3-D printing manufacturing process, risk reduction opportunities, and the microbiological impact of printing recycled raw materials. The microbiological risk assessment will bediscussed, supported by experimental data to understand the expected bioburden and endotoxin levels at various stages ofmanufacture and potential raw material reuse. Recognizing the resorbable nature of this device, considerations to the sterility ofinternal surfaces of the sterilized part will also be discussed.
“European Union’s MDR and its impact on tests, validations and biological evaluation for Medical devices (transient use), implants and surgical instruments. An overview.”
Compliance to the EU’s Incoming medical MDR required reinforced strategies and test plans to obtain satisfactory levels for the notified body and authorities. This presentation will illustrate some important changes and their impacts for the manufacturer.
What topic would you like to learn more about ?
We have reserved this slot for your personal enquiries. Is there a specific subject you want to learn more about ? In MedBraid’s registration page, leave us your recommendations and we will tailor the presentation to your liking and the availability of our experts.
Please click here to get access to the MedBraid 2019 official Schedule.
MedBraid 2019 will be chaired by Johnathan Linttot, founder and director of Andersen Caledonia.
The presentations will be brought you by:
Michael Mayer, Senior Partner at Medidee
Yacine Gerard, Quality Manager at Medistri S.A
Gilles Farron, Biologist and Laboratory Manager at Medistri S.A
Sandra Klompmaker, Senior Associate at Medidee
Dawn Nestola, Manager, Microbiological Quality & Sterility Assurance at DePuy Synthes (Johnson & Johnson)
Please click here to learn more about our experts and chairman.
The entrance fee to the event is CHF 200.-. Included in the ticket are:
Full-day access to all the presentations
Access to Swiss Medtech Expo
One-to-One expert consultation
Online access to lectures
Stand-up Lunch & refreshments
Afternoon networking aperitif
Click here to read our frequently asked questions.
MedBraid 2019 is brought to you thanks to: