Resources
Resources to help build a stronger science-based community.
Our Presentations
Frestedt Incorporated staff are often asked to speak at professional organization events or client specific training sessions. Below, you’ll find some of our presentations. Contact us if you would like more information on a specific clinical, regulatory, quality or engineering topic.
European Union (EU) Post-Market Surveillance (PMS)
Team training on MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices December 2025 on 16FEB2026. LINK TO DOWNLOAD AND VIEW PDF
The ODD couple: Clinical Risk Management via ISO14155 and ISO14971
Thursday, April 24 from 8:40am – 9:40am PT The integration of device engineering risk concepts into clinical trial risk management activities is advancing at a fast clip. In addition, the identification of pre-defined and pre-quantified safety and performance acceptance criteria
Good Clinical Practices & Quality Assurance
Saturday, July 22 from 9am – 11am (2 hours) The overall theme is the role of Quality in GCP. This class was offered as part of the MTQ – 620/RAS 633 course on Medical Device Quality & Regulatory Fundamentals at
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
Link to download PDF
FDA Pharmaceutical Industry Guidance Review: ICH E8 & ICH E6 (R2)
Link to download PDF
Investigational New Drug Application (IND) Annual Reports
Link to download PDF
ISO 14155:2020 Clinical Investigation Planning (July 2020)
Link to download PDF