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  FDA Cybersecurity Draft Guidance

  The FDA released a new Cybersecurity draft guidance on April 2022. It is intended to replace the current final guidance from 2014 which is well overdue an update. The draft guidance significantly expands requirements for cybersecurity activities and documentation for medical devices. The intention is to align medical device development with current best practices from other industries. This white paper reviews these new requirements and considers their impact on medical device developments.

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  Writing Effective SOPs for Manufacturing Medical Devices

  Writing and implementing standard operating procedures (SOPs) for the manufacture of medical devices is required by ISO 13485, FDA, and other regulatory bodies. An SOP is a set of written instructions that documents a routine or repetitive activity that is followed by employees in an organization. The development and use of SOPs are integral parts of a successful quality system. They provide directions to perform a job properly and consistently to achieve predetermined specifications and quality end results. SOPs address all requirements to complete the job or process safely and effectively.

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  Considerations for Medical Device Image Sensors

  Considerations for selecting medical device camera image sensors including CCD vs. CMOS and monochromatic vs. color varieties.

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  When Tolerance Studies Add Value in Medical Device Development

  Examples of how to apply tolerance studies that add value to medical device design and ultimately to biomedical start-ups.

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  Reducing Costs in Medical Device Verification and Validation

  How to identify hidden costs in medical device Verification & Validation along with mitigation measures to reduce the expense. 

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  Tips to Avoid Medical Device AI Pitfalls

  Exploration of the potential in using Medical Device AI with tips on how to avoid pitfalls in AI implementation.

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  Preparing EUA Medical Devices for Post-Pandemic Use

  Review of the FDA transition plan for medical devices currently marketed under Emergency Use Authorizations with implications for devices.

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  Regulatory Science Tools Reduce Risk in New Medical Devices

  How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.

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  Integrating Microfluidics into Biomanufacturing

  Integrating Microfluidics into Biomanufacturing overview and top 4 enabling features of microfluidics for biomanufacturing.

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