White Papers
Auditing 101 – Part 3: Prepare, Conduct, Host, & Respond – Navigate for Success
Get ready for the third installment of our Auditing 101 series: "Prepare, Conduct, Host, & Respond – Navigate for Success." Building on our previous discussions about the principles of medical device auditing and constructing a robust audit management process,...
Case Studies of Decentralized Clinical Trials
Understanding the subtle yet impactful differences between hybrid and fully virtual Decentralized Clinical Trials (DCTs) is crucial. Are you ready for your DCT trial? Have you considered all aspects? This MEDIcept White Paper dives deep into the discrepancies we...
Auditing 101 – Part 2: Constructing for Continuous Control & Improvement
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...
Risk Management Series – Part 1: Prioritizing Risk Management Activities
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...
Auditing 101 – Part 1: Fundamentals of Medical Device Audits
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...
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...