White Papers
DCT Virtual Device Trial Training and Common Challenges
Are you facing challenges with managing your Decentralized Clinical Trial (DCT)? This MEDIcept White Paper is here to help! DCTs have been taking the clinical research landscape by storm and offer many advantages compared to traditional clinical trials. DCTs can...
CAPA, Nonconformance, and Complaints – Oh My!
This White Paper dives into the interconnected world of Corrective and Preventive Action (CAPA), Complaint management, and Nonconformance systems. Discover how they collaborate to safeguard product quality and enhance overall QMS efficiency. Avoid common pitfalls and...
Securing Medical Devices: FDA’s Final Premarket Cybersecurity Guidance
In an age where technology and healthcare converge, ensuring the security of medical devices has never been more important. The year 2023 marks a significant milestone in the evolution of medical device cybersecurity as FDA unveiled its final guidance on premarket...
From Computer Software Validation (CSV) to Computer Software Assurance (CSA): Arena QMS Case Study
Want to learn more about the potential of modern automated process technologies, like Arena Quality Management System (QMS) and Product Lifecycle Management (PLM) for elevating medical device quality, availability, and safety? You’re at the right place. Our...
3 DRAFT GUIDANCES: Keeping in Step with the 510(k) Medical Device Program Modernization
It can be hard to keep up with FDA’s latest regulatory intelligence, trust us, we know! When we say STOP, save these 3 guidance documents and sign up for FDA’s webinar please listen. Best Practices for Selecting a Predicate Device to Support a Premarket Notification...
Supplier Quality Management: A Summarized Approach
Want to learn more about the importance of effective supplier controls and management in the context of medical devices? You’re in the right place! This White Paper covers the different aspects of supplier quality management including: the fundamental role of...