The partnership seeks to address the increasing regulatory and operational demands for robust, life-cycle-spanning medical ...

Beyond the standards and frameworks, how do secure-by-design tenets become practical, repeatable and scalable?

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

Among the fields mushrooming at a very high speed, medicine is one of the trending. It is rapidly growing now, primarily through the application of digital means. Digital health software development ...

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FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. FDA plans to pilot Real-World ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

In-house and private practice counsel set out the challenges and opportunities of protecting software in medical devices and software as a medical device Medical device manufacturers have been ...

On November 4, 2021, FDA released a draft guidance for public comment entitled “Content of Premarket Submissions for Device Software Functions” (the “2021 Draft Guidance”). In its final form, this ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Hacking pacemakers and insulin pumps is mostly hype; thankfully the scary stories are just that, scary possibilities that could supposedly happen if attackers were to target vulnerable devices. Some ...