This year’s Biocompatibility Insights conference took place in Annapolis, MD, US from September 25–27, 2023. The framework for the event was “Exploring the science behind the regulations” with the sub theme “Addressing challenges in medical device toxicology. Keynote...
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...
Substance-based Device Regulation
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: The goal of this training is to provide participants with an introduction to substance-based...
EUDAMED
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 EUDAMED and its functional specifications Interpret EUDAMED data...
Person Responsible for Regulatory Compliance (PRRC) – EU & Swiss Regulations
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 regulatory context of PRRC roles and responsibilities in both EU and CH...