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Does Size Matter? Rescue from a large CRO

THE CHALLENGE Missed timelines and EDC build errors compromised the potential success of the company’s phase 1 study.THE SOLUTION Experienced team members and robust internal reviews resulted in a timely, high-quality EDC build and data management plan.THE OUTCOME...

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...

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...