White Papers
2023 Clinical 483 Inspection Observations Trends
First Quarter 2024 Clinical 483 Inspection Observations are Tracking to 2023 Trends. How to Stay Ahead with a Winning Strategy! Are you curious about different ways to avoid a 483 violation? Then this MEDIcept White Paper is for you! Each year, FDA compiles a list of...
Building a Better SBOM with Build SBOMs
Dive into MEDIcept's latest white paper on Building Software Bills of Materials (SBOMs) to safeguard against cyber-attacks targeting Healthcare Delivery Organizations. Learn why SBOMs are pivotal for understanding and managing vulnerabilities in medical devices,...
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Draft Guidance: Characterization of Metallic Coatings and/or Calcium Phosphate Coating on Orthopedic Devices
New Draft Guidance from FDA!!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...