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  Submitting a medical device application under the Health Canada Interim Order

  Author describes her experience submitting a medical device application (ventilator) under the Health Canada Interim Order.

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  How much does it cost to develop a medical device?

  The amount of total company funding to develop a Class II 510(k) cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. This estimate is built upon a meta-analysis of various references as well as our experiences in engaging with companies. Many factors influence these costs, including the need for clinical studies, regulatory pathway, and technology complexity. Refinement of these numbers requires a professional team to understand the technology, regulatory, and business opportunities.

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  How to turn patient imaging data into functional 3D models

  How to create accurate and functional 3D models from patient imaging data. Develop anatomically accurate prototypes for medical device design.

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  Three Considerations for Water Ingress in Medical Devices

  One of the key requirements for ISO 60601-1 is the protection against water ingress in Medical Devices. Three areas to watch are discussed in this article..

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  Planning and Conducting Summative Usability Testing

  There are a lot of things to consider when creating a summative usability test. The first time can be overwhelming. What scenarios do I test? How do I identify a critical task? How many participants do I need? Do I need to test the training? In this eGuide I will help you avoid common mistakes, like using a formative test structure for a summative usability test. I will also provide some tricks and tips to help you get the most out of your test participants and testing.

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  Michael May discusses the intersection of medical devices in regenerative medicine

  Michael May, President and Chief Executive Officer of CCRM discusses the intersection of medical devices in Regenerative Medicine.

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  How Regenerative Medicine will transform therapeutic medical devices

  Regenerative Medicine (RM) therapeutic medical devices transform healthcare. The role of Medical Devices in the RM industry is changing.

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  Two considerations for regenerative medicine medical device design

  Two things you should consider in order to be successful when you are developing a Regenerative Medicine Medical Device Design

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  Fighting acute lymphoblastic leukemia (ALL) with CAR-T regenerative medicine

  Chimeric antigen receptor T-cell (CAR-T) therapy is a rising shining star in Regenerative Medicine.  Medical devices will be involved.

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