Free Webinar – Principles For Validation of Reprocessing for Reusable Medical Devices
REGISTER HERE WHY I SHOULD JOIN THE WEBINAR: Reprocessing is a process carried out on a used device in order to allow its safe...
Free Webinar – Safety is more than biocompatibility: MDR general requirements and ISO 10993 series
REGISTER HERE WHY I SHOULD JOIN THE WEBINAR: “Safety” is mentioned almost 250 times in the MDR 2017/745 and our glorious “essential requirements” of...
Free Webinar – Animal Origin Materials: Changes to ISO 22442-1:2015 & ISO 22442-2:2015
REGISTER HERE WHY I SHOULD JOIN THE WEBINAR: A medical device containing animal origin material (or animal origin material is used as a manufacturing...
Free Webinar – Extractables & Leachables: Regulatory aspects, risk assessment and design of experiment
REGISTER HERE WHY I SHOULD JOIN THE WEBINAR: A drug product container-closure system should not release chemicals that can accumulate in the drug in...
Free Webinar-European CE Technical File Compilation for Medical Devices under MDR
REGISTER HERE WHY I SHOULD JOIN THE WEBINAR: Before placing a medical device on the European market, manufacturers need to produce technical documentation as...
Free webinar – Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” – Guidance for Industry and Food and Drug Administration Staff
WHY I SHOULD JOIN THE WEBINAR: FDA just revised this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs),...
Free webinar – Nitrosamine Impurities: Risk Based Approach & Testing. Steps Towards Fulfiling EMA & FDA Nitrosamine Advice
WHY SHOULD I JOIN THE WEBINAR? Eurofins BioPharma Product Testing Italy and Li-Med invite you to participate at our free webinar on nitrosamines analysis....
Free webinar – The new ISO 10993-18:2020: Chemical characterization of medical device materials within a risk management process
WHY SHOULD I JOIN THE WEBINAR? The new version of ISO 10993-18 Chemical Characterization of Medical Devices has been published in January 13th, 2020....
Free Webinar – Be prepared for EO sterilization validation
Why should I join the webinar? In this webinar, we will: Learn what are the critical parameters of EO sterilization process and what impact...
ISO 10993-18:2020 – Chemical characterization approach as a prerequisite for biological risk evaluation
WHY SHOULD I JOIN THE WORKSHOP? The new version of ISO 10993-18 Chemical Characterization of Medical Devices has been published in January 13th, 2020....
MDR MASTER CLASS
WHY SHOULD I JOIN THE WORKSHOP The workshop “MDR MASTER CLASS” blends Academy and Industry to offer the most modern education for Medtech and...
Usability -No more the abandoned field
EVENT DESCRIPTION The impact of regulatory requirements in design and post-market phases of medical devices; Usability and usability engineering process in human errors prevention;...
Best Practices for Extractables and Leachables Studies in the Pharmaceutical and Medical Devices Industry
EVENT DESCRIPTION The importance of extractables and leachables testing in the pharmaceutical and medical device industry has grown significantly in the last few years...
Clinical Evaluation of Medical Devices CER: MDD vs MDR
EVENT DESCRIPTION Medical devices require CE Marking for their commercialization in the European Union. When submitting devices for a CE Mark, manufacturers must provide...
Digital Testing for Medical Device
EVENT DESCRIPTION Medical devices and healthcare systems represent a growing risk to hospitals and medical centers. The threat is not only to sensitive data,...
Sterilization Validation and Cleaning Validation
EVENT DESCRIPTION Manufacturers of finished medical devices should provide clear, understandable and reproducible cleaning and sterilization protocols that have been validated to be effective....
Biological evaluation of medical devices
EVENT DESCRIPTION The main scope of ISO 10993 is to protect patients from biological risks arising from the use of medical devices. The standard...