Dive into the intricacies of auditing within the medical device industry with the latest MEDIcept White Paper! In this insightful piece written by Quality Systems Consultant, Jeff Groskopf, he explores the pivotal role audit management plays in fostering a culture of...
Join us for Part 1 of our Risk Management Series where we tackle the challenge of prioritizing risk management activities in medical device development. In this White Paper, we delve into the common pitfalls faced by both large companies and startups, providing...
Are you seeking to improve your understanding of medical device audits? Does auditing burden your company or are you failing to receive the improvement benefits?  MEDIcept and this White Paper are here to help. Auditing 101 is an ongoing series of papers that will...
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...
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,...
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...
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...
New Draft Guidance from FDA!!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...
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...
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! Â This MEDIcept White Paper will discuss all things safety committees including their definition,...