White Papers
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...
Use of Safety Committees in Clinical Trials: When to Engage CEC, DSMB or Both?
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! This MEDIcept White Paper will discuss all things safety committees including their definition,...
Post Market Surveillance – The Missing Link – How Companies Gain Real World Experience
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...
Wearables in Real-World Evidence (RWE) Clinical Trials
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...
Cybersecurity in Medical Devices- Quality System Considerations and Content of Premarket Submissions
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...
Regulatory Round-Up
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...