Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our lives. Among these, medical devices stand as a promising frontier. The unique properties of nanomaterials, stemming from...
Biocompatibility of Medical Devices: Process, Detailed Steps and 7 Hot Topics to Crack the Code of Medical Device Safety
The landscape of modern healthcare has been completely transformed by the development of cutting-edge medical devices. From life-saving implants to innovative surgical tools, these medical devices have become indispensable in healthcare. However, behind every...
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...
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...
US Regulations for EU Companies – Introduction to the FDA Regulations for Medical Devices
Speaker: Paige Elizabeth Sutton-Smith, Project Associate Date: October 3rd-4th 2023, Online Duration: 6 hours | 2x 3:00 – 6:00 PM CEST, 9:00 – 12:00 AM EDT Training Objectives: This training will introduce the FDA regulations for medical devices, with a focus on...
UK Medical Device Regulations – Understand the Regulatory Landscape of one of the largest Medical Device markets in Europe
Speaker: Somashekara Koushik Ayalasomayajula, Senior Consultant Date: November 7th 2023, Online Duration: 4 hours | 2:00 – 6:00 PM CET, 8:00 – 12:00 AM EDT About the Speaker: Somashekara Koushik Ayalasomayajula is a polymer engineer with 4+ years of experience within...