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...
We are living in the age of information, everywhere we turn there is data being collected, analyzed, shared, and stored. As technology evolves and is applied to healthcare, this principle remains true as large amounts of real-world data (RWD) is collected and...
Are you interested in implementing cybersecurity controls in your medical devices? You’re in luck! This MEDIcept White Paper will discuss all things cybersecurity with a focus on quality system considerations and the content of premarket submissions.  Discover...
With updates and guidance getting published constantly, it can be difficult to keep up with everything regulatory bodies come out with. On top of that, determining what is applicable to a specific device can be even more difficult. This White Paper discusses...
Are you facing challenges with managing your Decentralized Clinical Trial (DCT)? This MEDIcept White Paper is here to help! Â DCTs have been taking the clinical research landscape by storm and offer many advantages compared to traditional clinical trials. DCTs can...
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...
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...
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...
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...
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...