Mastering Time and Compliance How to Deal with Regulatory Requirements when Collecting Clinical Performance Data IVDR imposes stricter requirements for clinical evidence, including a higher level of scrutiny and more stringent criteria for study design,...
Webinar – 2024 IVDR Sprint Series: The Clinical Challenge – Addressing Increased Evidence Requirements in the EU IVDR Era
The Clinical Challenge Addressing Increased Evidence Requirements in the EU IVDR Era In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of...
Webinar: The Impact of the Cleaning Process on Sterilization Validation and Biocompatibility Activities
The Impact of the Cleaning Process on Sterilization Validation and Biocompatibility Activities The achievement of a suitable level of cleanliness in the manufacturing of medical devices is an indispensable precondition to providing patients, users and...
Webinar: Introduction to ISO/IEC 27001 – Information Security Management Systems
Introduction to ISO/IEC 27001 - Information Security Management Systems A key component to protect your data Information security is a critical field dedicated to safeguarding an organization's digital assets, data, and information systems from unauthorized...
Webinar: Regulatory Strategy for New Neurological Medical Devices
Regulatory Strategy for New Neurological Medical Devices Considerations for an effective balance between non-clinical and pre-clinical evaluations Regulatory considerations and preclinical aspects are major parts of getting any medical device to market. Finding...
Webinar: Medical Devices Incorporating or Generating Nanomaterials
Medical Devices Incorporating or Generating Nanomaterials What manufacturers should consider to ensure safety and biocompatibility The concept of nanomaterials and their possible applications was first introduced by Richard Feynman, which earned him the...
EN ISO 13485:2016 – Quality Management System (QMS)
This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned. Training Objectives: Understand the QMS principles and the links between the different QMS processes Define...
Overview of the PMS and PMCF requirements under the Medical Device Regulation (MDR)
This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned. Training Objectives: Understand Post Market Surveillance (PMS) & Post Market Clinical Follow-up (PMCF)...
Electrical Safety
This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned. Training Objectives: Gain a general understanding of IEC 60601 standards (collateral and particular...
Cybersecurity
This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned. Training Objectives: This training is intended to allow the participants to understand the requirements...