Gabe Siftar and Matt Nowell
Gabe Siftar and Matt Nowell

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

By Gabe Siftar, Matt Nowell

The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.

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Steve Thompson
Steve Thompson

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach

By Steve Thompson

When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.

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Binary code
Binary code
Soapbox

Automating Computer Systems Validation for Your QMS

By Davor Milosevic, Massimo Franza

Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.

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Brad Jolly
Brad Jolly
MEDdesign

Five Critical Considerations for Connected Health Manufacturers

By Brad Jolly

Internet-enabled medical technologies have significantly improved the standard of care. They have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or, in some cases, eliminated—in the engineering and design phase. Following are five key considerations for manufacturers to help foster connected healthcare’s continued acceleration.

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Darren Porras and Stuart Kozlick, RTI
Darren Porras and Stuart Kozlick, RTI
MEDdesign

Intelligent Software Connectivity: An Opportunity to Transform Device Development and Health Care

By Darren Porras, Stuart Kozlick

MedTech is evolving from siloed products and devices to increasingly multi-functional and integrated digital systems, and device manufacturers are faced with significant challenges in bringing these connected solutions to market. Slow and expensive development lifecycles, complex and inflexible device architectures, and the need for increased cybersecurity, are among the key challenges. The solution lies in a new generation of devices powered by intelligent software data flow.

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Cybersecurity
Cybersecurity

Managing Legacy Technology Security

By MedTech Intelligence Staff

A new guide from the Healthcare and Public Health Sector Coordinating Council recommends cybersecurity strategies that manufacturers and health providers can implement for legacy medical technology as a shared responsibility in the clinical environment, and provides insights for designing future devices that are more secure.

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Dr. Abtin Rad
Dr. Abtin Rad

New Cybersecurity Standards for Medical Applications

By Dr. Abtin Rad

Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.

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