White Papers
510(k) Submissions for Devices Labeled as Sterile: How to Approach the Inclusion of Sterility Information
The landscape surrounding Medical Device Sterilization has evolved as FDA looks to dedicate resources, develop programs, and foster innovation in the field. To reflect these changes, FDA released the updated final guidance document “Submission and Review of Sterility...
Risk Management Series Introduction – Beyond FMEA
Are you looking to improve your risk management system? Having trouble ensuring you are complaint with ISO 14971:2019, IEC/TR 80002-1:2009 and other risk management standards? This MEDIcept White Paper is here to help. This paper will serve as an introduction to an...
Draft Guidance: Characterization of Metallic Coatings and/or Calcium Phosphate Coating on Orthopedic Devices
New Draft Guidance from FDA!! Do you work in the orthopedic devices space and would like to have a better handle on the submission requirements for devices with metallic and phosphate coatings? Look no further! On January 23, 2024, the Federal Register announced a...
IVDR Impact on Small and Medium Sized Enterprises (SMEs)
Are you a small or medium enterprise unsure how to approach the IVDR transition? Are you facing challenges and not sure how to overcome them? This MEDIcept White Paper is here to help. This paper will explore the differences between the IVDD and IVDR, QMS...
Use of Safety Committees in Clinical Trials: When to Engage CEC, DSMB or Both?
Are you unsure whether or not you need a safety committee, which one to use and when you should employ them in your clinical trial? This MEDIcept White Paper is for you! This MEDIcept White Paper will discuss all things safety committees including their definition,...
Post Market Surveillance – The Missing Link – How Companies Gain Real World Experience
Post Market Surveillance is an essential step in ensuring your device is still meeting the needs of users and patients and is functioning as designed once it is on the market. Implementing a process to monitor this data is essential, and this White Paper is here to...