What Information FDA is Expecting for Cyber Devices?
In an era where medical devices are increasingly interconnected and
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Learn more about Medical Device AppsCybersecurity Quality & Regulatory
Ensuring Secure Software Updates for Medical Devices
While remote software updates for medical devices have traditionally been
New Cybersecurity Regulations Make Remote Software Updates Practically Mandatory
A startup recently shared with us that they were considering
6 pitfalls to avoid when developing mobile apps for medical devices
In the bustling healthcare landscape, the mHealth market—estimated between $50
You don’t need a full QMS: Leverage your development partner and contract manufacturer
In today’s competitive and fast-paced market, efficiency and lean operations
What’s the simplest QMS your medical device startup can implement and still be compliant?
Implementing a Quality Management System (QMS) for a medical device
5 reasons FDA will refuse your 510(k) application due to cybersecurity deficiencies
Over the past decade, the FDA has steadily increased the
Why avoiding Q-subs (presubmissions) to FDA is a terrible idea
In the realm of medical device development, ensuring the safety,
Why ISO 13485 Certification Matters in Product Development
https://www.youtube.com/watch?v=FX8b5Bpzw4c Bold Type achieved ISO 13485 certification this year. And
Understanding the connected, wireless medical device development process
https://www.youtube.com/watch?v=kmWs3VcBgb4 Today I want to talk about the process for
Three Connected Medical Device Stakeholders
https://www.youtube.com/watch?v=3BH1jpXtjGI Connected wireless medical devices bring benefits to three key
How to add cloud connectivity to medical devices
https://www.youtube.com/watch?v=3BH1jpXtjGI Bold Type president Jose Bohorquez shares how to add cloud connectivity to
3 questions to ask before picking a connected medical device product development firm
Get satisfactory answers to these three questions or move on.