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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  FDA Cybersecurity Draft Guidance

  The FDA released a new Cybersecurity draft guidance on April 2022.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 The draft guidance significantly expands requirements for cybersecurity activities and documentation for medical devices.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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  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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  XYZs of Medical Device Vibration Testing

  XYZs of Medical Device Vibration Testing shares the basics of vibration testing from equipment to key concepts and definitions.

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  8 Tips to Manage Medtech Stakeholder Expectations

  Tips and lessons learned on how to manage medtech stakeholder expectations gleaned from 25 years of medical device development.

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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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  7 Polarities in Medical Device Product Commercialization

  Seven Medical Device Commercialization Polarities with tips on how to manage them throughout the development and commercialization process.

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