MedBraid 2019.
Messe Luzern, Switzerland
For the fifth edition of MedBraid, we presented this year’s event in collaboration with Swiss Medtech Expo Luzern. The event was focused on the themes of EU’s MDR, Biocompatibility, Validation and Sterilisation of Medical Devices.
“Biocompatibility: Understanding the new ISO 10993”
“Ethylene Oxide Sterilisation: The development & validation of effective processes”
“Complying with the European Union’s MDR”
“Additive Manufacturing (3D Printing) Microbiological Considerations for DePuy Synthes Resorbable Polymeric Patient Specific Implant”
“Medical device cleanliness. Compliance to MDR 2017/745: impact of biological and chemical testing. An overview.”
“Sterile Packaging of Medical Devices - Impact of MDR”
MedBraid 2017.
Messe Luzern, Switzerland
For the fourth edition of MedBraid, we presented the event in collaboration with Swiss Medtech Expo Luzern.
“ Design and development of sterile medical devices”
“Challenges and solutions for EtO sterilization”
“Challenges and solutions for Gamma sterilization”
“Notified body assessment of sterilization validation file”
MedBraid 2015.
Zurich, Switzerland
The third edition of MedBraid in Zurich, focused on manufacturing and sterilisation.
“Steam sterilisation”
“EtO Sterilization, understanding the regulatory requirements”
“Radiation Sterilization, Gamma”
“Practical aspects of sterilization with E-Beam”
“Cleaning validation of invasive Medical Device”
“Characteristics of medical device to be provided sterile”
“Packaging design for different types of sterilisation”
“Packaging validation”
“EU Regulation for reprocessing SUD”
MedBraid 2010.
Zurich, Switzerland
The second edition of MedBraid in Zurich. it was an opportunity to share the basics, interpretations, applications & update with recent changes.. The seminar covered issues related to manufacturing of products, microbiological contamination of product, clinical trial & sterilization.
“Clinical evaluations and clinical trials for medical devices”
“EN ISO 11607(2006): Packaging for terminally sterilised medical devices”
“Microbiological Monitoring of Medical Devices and Clean Rooms – Importance and Approaches based on ISO 11737-1 and ISO 14698-1/-2 respectively”
“EN ISO 11607(2006) : Packaging for terminally sterilised medical devices”
“Water used in Medical Devices Manufacturing – European and US pharmacopeias”
“Method for prediction of ethylene oxide lethality and cycle development”
“Directive 2007/47 EC - Successful implementation of the key revisions to the medical device directives”
“US-FDA 510(k) submissions- Requirements and their practical implementation”
“Software Development Lifecycle (IEC 62304)”
MedBraid 2008.
Zurich, Switzerland
The first edition of MedBraid in Zurich. Professionals of the Medical Devices and Pharmaceutical sector were present at the only seminar in Switzerland where we discussed the efficiencies of the major sterilisation methods including practical demonstration of the latest regulatory requirements and changes.
“Radiation: Requirements for development, validation and routine control of a sterilisation process for medical devices”
“Ethylene oxide: Requirements for development, validation and routine control of a sterilisation process for medical devices”
“Microbiological methods: Determination of a population of microorganisms on products”
“Packaging for terminally sterilised medical devices: Requirements for materials, sterile barrier systems and packaging systems”
“Packaging for terminally sterilized medical devices: Validation requirements for forming, sealing and assembly processes”
“Biological evaluation of medical devices: Ethylene oxide sterilization residuals”
