White Papers
Design Control: From Evolution to Commercialization
Are you in the early stages of design development of a product? Or do you need help remediating your Design History File? This White Paper will provide guidance on the global requirements of design control and the documented evidence needed to meet global regulatory...
The Future of Clinical Trials Series: Decentralized Trial (DCT) Supply Management and Navigating Complexities
With the increased popularity of the decentralized and hybrid models of clinical trials come unique challenges, especially regarding investigational device management and training execution. In this new MEDIcept White Paper, the importance of supply and training...
Cybersecurity 2030: Emerging Trends in Medical Device Cybersecurity
How do you predict what cybersecurity requirements will be at the end of your product development lifecycle? Technology evolves rapidly, and with it, technological capabilities of threat actors seeking to profit or cause harm from malicious activities targeting...
How, When, and Why to Leverage the FDA’s Safer Technologies Program (STeP)
Are you in early stage development of a device or device-led combination product? The FDA has rolled out a number of initiatives over the past several years to facilitate more timely access for patients to innovative medical devices and technologies. One such...
Falling Out of Compliance: When Quality Auditing Comes Too Late
Whether you are a start-up company or a well-established business, auditing is not only an integral part of the business process, but also a requirement. Knowing the right timing to implement the quality audit program within the quality system lifecycle and how audits...
Device Software and Data Collection Transparency
Decentralized clinical trials (DCTs) are becoming more and more popular as a means of improving patient access and participation, reducing costs, and increasing efficiency. However, DCTs also present unique challenges in terms of data collection and management,...