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  Risk Management for Medical Device Projects

  Proven approach to medical device development risk management using an every day concept using plan, risks, opportunities, and actions.

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  High Level Program Planning: A Journey, Not the Destination

  Six common medical device product development destinations and overview of a High Level Program Planning (HLPP) approach.

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  Premarket Submissions of Device Software Functions

  Learn about the FDA’s 2023 guidance on premarket submissions for device software functions and its impact on the medical device industry.

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  FDA Cybersecurity Draft Guidance

  The FDA released a new Cybersecurity draft guidance on April 2022.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 The draft guidance significantly expands requirements for cybersecurity activities and documentation for medical devices.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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