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  Increasing IVD Regulatory Success

  Tips, considerations, and techniques to increase IVD Regulatory Success that is essential for many Medical Devices.

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  Re-use IVD Verification Test Equipment in Optics Manufacturing QC

  Reduce costs by reusing IVD Verification Test equipment for verification of optical components as part of manufacturing quality control.

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  Low Cost Optical Sensing Techniques for Point of Care IVDs

  Many (IVDs) employ optical techniques to sense. How to develop low cost IVDs suitable for Point of Care use – optical sensing.

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  Electro-Medical Device Basic Safety Learning Lab Highlights

  Highlights from Day 1 of Learning Lab event at Boston BIOMEDevice on electro-medical device basic safety and achieving compliance with 60601.

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  Proven Process for Medical Device Success: Part 2 – Regulatory to Design for Manufacture

  Proven Process for Medical Device Success– Pathfinder Process: Regulatory, Human Factors and Workflow, Technology Assessment, Design for Manufacture.

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  Using Proven Process for Medical Device Success: Part 1 – IP to Reimbursement Strategy

  Medical Device Pathfinder process for Intellectual Property, Consumables Strategy, Value Chain and Margin, and Reimbursement.

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  Avoid Waste Preparing for Medical Device Regulatory Requirements

  The best way to avoid waste is to consider medical device regulatory requirements at a project outset.

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  How to Handle Medical Device Risk Management and the change from ALARP to AFAP

  Medical Device Risk Management ALARP to AFAP, the Directive and Standard, implications and how to handle the situation.

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  Medical Device Design Documentation Risk Management, Verification & Validation (V&V), and Standards Tips

  Risk Management, Verification & Validation (V&V), and Standards tips for Medical Device Design Documentation. FDA 21 CFR 820 QSR regulations.

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