Regulation and quality assurance are significant and integral parts of medical devices development processes
In order to keep you updated in the latest, most important aspects of both regulatory rules and quality assurance, we offer a series of conferences and seminars to assist you in your path towards being approved by the FDA, CE, ISO etc.
The next coming conference:
MDR MASTER CLASS:
Workshop for the Israel MedTech Industry
December 8th, 2019
David Intercontinental Hotel, Tel-Aviv
Keynote Speaker: Dr. Monica Tocchi, Medical Director of Meditrial
March 14th, 2019
January 17th, 2019
This conference is designed to deliver valuable insights to manufacturers on how to demonstrate clinical safety and performance of their products in compliance with the strict requirements of the MEDDEV 2.7/1 rev.4 and in compliance with the new EU MDR. By attending the conference participants will be able to:
• Understand what is included in the term ‘Clinical Data’;
• Understand what is required regarding ‘Current Knowledge & State of the Art’;
• Understand how clinical evaluation is a process, and how this process needs to be interlinked with Risk Assessment, Usability and Biological Risk assessment;
• Determine when a clinical trial is required;
• Know how to provide documentation in support of the clinical safety and performance of devices;
• Ensure continuing compliance throughout device life-cycle.
The following topics will be discussed at the conference
Objective of Clinical Evaluation Process & Report (Danielle Nusimovici-Avadis MD, DNA Consulting)
Clinical Evaluation: MDD vs MDR (Danielle Nusimovici-Avadis MD, DNA Consulting)
CER and relevant Harmonized Standards:
- EN ISO 14155:2011 and expected updates in 2019 (Danielle Nusimovici-Avadis MD, DNA Consulting)
- EN ISO 14971:2012 RISK Assessment (Ruth Reiss, Li-Med)
- IEC 62366-1/2 USABILITY (Danielle Nusimovici-Avadis MD, DNA Consulting)
Clinical Evaluation: New definitions; Procedure & Report (Danielle Nusimovici-Avadis MD, DNA Consulting)
CER Table of Content – Template (Danielle Nusimovici-Avadis MD, DNA Consulting)
October 11th, 2018
- Challenges in digital health application development /Moshe Klaiman (Medix)
- Cybersecurity in Medical Devices - regulatory overview/ Orly Shenkar (Li-Med)
- Eurofins cybersecurity overview /Marcel Mangel (Eurofins Cyber Security Services)
- UL 2900 standard/ Marcel Mangel (Eurofins Cyber Security Services)
- Engaging the cyber security team /Marcel Mangel (Eurofins Cyber Security Services)
February 27th, 2018
ETO Sterilization of Medical Devices
Cleaning & reprocessing validation
Endotoxin contamination after sterilization: FDA expectation
ISO 10993-7:Ethylene Oxide Sterilization Residuals More Info & Registratio
November 16th, 2017
The following topics were discussed at the conference:
- 10993 standard series: approaching bio-compatibility within a risk management process.
- Introduction to the new FDA guidance.
- Chemical characterization of the materials: what does it means in practice.
- Toxicological assessment (ISO 10993-17) application in order to evaluate obtained data from chemical characterization.
- Bridge approach and change management optimization thanks to chemical characterization Bio-compatibility tests overview.
- What’s new in ISO Technical Committee 194 “Biological and clinical evaluation of medical devices”: an update from October 2017 meeting in Seoul
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