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  5 Tips for medical device cyber security

  Basics of cyber security as it relates to medical devices, and five tips for developing hack resistant medical devices.

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  Staffing a Medical Device Start-Up

  Staffing a Medical Device Start-Up: shortlist of job descriptions required to develop a complex, novel medical device.

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  5 Similarities and Differences between Medical Device 510(k) and CE Marking Pt. 2

  Highlights of 510(k) and CE Marking similarities and differences. Explore the Quality Management System (QMS) and Documentation aspects.

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  5 Similarities and Differences between Medical Device 510(k) and CE Marking Pt. 1

  Medical Device 510(k) and CE Marking similarities and differences to help companies effectively prioritize their regulatory efforts.

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  Choosing injection molding partners (Pt. 2)

  Medical Device injection molding partnering tips and considerations: Validation, Cost Benefit Analysis, Vendor Quality Certification.

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  How to choose injection molding partners (Pt. 1)

  Selecting the right injection molding partner is crucial. Costs and timescales can be a significant part of a project budget. PT 1 of 2

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  Update on IEC60601-1-2 (2014) 4th Edition

  Analysis of IEC60601-1-2 (2014) 4th Edition update. Includes examples and impact on medical device regulatory testing and commercialization.

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  Sorting Through New and Final FDA Guidance Documents

  Highlights of July and August 2014 medical device FDA guidance documents that reduce regulatory burden without compromising patient safety.

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  IVD Algorithm Techniques

  Techniques for IVD algorithm development. IVD algorithm is often required to convert electronic sensor data into a clinical parameter.

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