Guest Columns
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Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
10/29/2024
In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.
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Adaptive AI-Driven Medical Devices In The U.S.: Ethical Considerations
10/28/2024
With the usage of AI in medical devices, ethical concerns center on patient health data, safety, and privacy, which adds an additional layer of complexity to design and development.
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Life Sciences Cybersecurity Incident Management: The End-to-End Approach
10/24/2024
Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.
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A New Approach To ISO 14971 For Better Medical Device Risk Analysis
10/23/2024
This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.
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The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
10/10/2024
The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.
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The ABCs Of PCCPs (Predetermined Change Control Plans)
10/10/2024
The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms. Software-enabled medical device companies that master this tool will be able to more rapidly improve their device products.
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Computer Systems Validation Pitfalls, Part 1: Methodology Violations
10/9/2024
When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.
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Sterility Assurance: The Fundamentals
10/8/2024
Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.
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Developing An Effective Patenting Policy To Protect AI-Enabled Medical Devices
10/7/2024
The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical recommendations and considerations.
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A Look Inside The Growing U.S. Market Landscape For Surgical Navigation & Robotics
10/3/2024
Surgical navigation and robotic systems are not novel technologies, but the market continues to grow in the United States. Growth rates per clinical application varies.