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...
Nanomaterials in Medical Devices: Biological Risks and Methodology for Biocompatibility Assessment
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...