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Services for technology companies

You can measure it. Now what?

Capturing biometrics is only the beginning. More requirements must be met before a great digital health solution can fill clinical gaps and lead to positive health outcomes. BML can help you go from cool new tech to legitimate digital health tool.

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Science and Tech

Get it right. Make sure your technology is doing what you think and it will stand up to scrutiny.

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Science and Tech
services include:

  • Science review

  • Algorithm design and development

  • Engineering verification

  • Data science (machine learning, AI, big data analysis)

  • Device benchmarking against industry gold standards

  • Application design and product/market fit

  • Biosignal acquisition and processing

  • Full service product development, including hardware, software and mobile apps

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Clinical Validation

Have it matter. Make sure your metrics and applications are scientifically shown to lead to positive health outcomes. Then prove it.

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Clinical services
include:

  • Pilot testing

  • UX design and analysis

  • Clinical validation

  • Project management

  • Product/market fit

  • Clinical partner connection and relationship management

  • Human Factors Engineering

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Regulatory Compliance

Make meaningful impact. Ensure you are well-positioned to reach the population you want to serve.

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We know the stakes are high and the runway is long. We believe in a lean, customized implementation of medical device requirements so you don’t run out of gas.

Regulatory Compliance
services include

  • Regulatory strategy and planning

  • Clearance for preliminary clinical validation (US IDE, Canada ITA)

  • Safety and biocompatibility testing

  • Support for medical device compliance in the US, Europe, Canada and all over the world

  • DHF / Technical file creation and support

  • Compliance submissions and portfolio management

Medical Device compliance includes ISO 13485 Medical Device Quality Management, FDA 21 CFR 820, CE MDD (93/42/EEC) and MDR (2017/745), Health Canada MDR, Australia TGA and Chinese cFDA, including MDSAP audit, ISO 14971 Risk Assessment, IEC 60601-1 Safety and Essential Performance, ISO62304 Software Lifecycle Management, ISO 10933 Biological Evaluation of Medical Devices and ISO 62366 Human Factors / Usability Engineering;