Design and Development Transfer Checklist
This checklist is intended to capture and guide the roles and responsibilities associated with the design & development transfer process.
Insights
Our team at Sunrise Labs has a lot of experience. They know the ins and outs of design and, engineering. Here they share their insights and how you can make the best medical products.
Data Management Methods
Sunrise Labs found investing in a fully integrated engineering database an invaluable data management method for teams collaborating in a shared space
Managing Requirements
A Systems Approach for efficient and compliant design and development of Medical Devices
10 Product Development Gotchas
Supporting over 30 client medical product development projects a year gives us a broad perspective and provides the opportunity to share key takeaways
Nordic’s Security Vulnerability
What the security vulnerability means for Bluetooth-enabled medical devices and how Sunrise Labs' risk management process pre-emptively minimized or eliminated the risks.
FDA Reduces Regulatory Barriers
The FDA reduced regulatory barriers for remote patient monitoring devices during the COVID-19 crisis.
Bluetooth LE Vulnerabilities
A set of Bluetooth LE vulnerabilities, collectively known as SweynTooth, brought attention to some straightforward attack vectors.
Medical Device Commercialization 101
Sunrise Labs has prepared an outline of the medical device business, development, and regulatory efforts required for the commercialization process.
Staying User-Centered
We have transitioned into an unprecedented landscape of remote work, here are some suggestions for staying user-centered.
Technology Readiness
This whitepaper outlines how to evaluate technology readiness for new concepts, and offers methods to improve the odds for successful commercialization.
Human Factors Usability Studies
Learn how to make your Human Factors (HF) usability studies less chaotic by investing in a small amount of planning and keeping some guidelines in mind
Postmarket Cybersecurity Management
Sunrise Labs offers a comprehensive assessment to mitigate cybersecurity risks for new medical devices and those that already exist on the market.