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  Update on Health Canada Activities and Changes

  2021 Update on Health Canada's medical device regulatory development during the COVID-19 pandemic and lessons learned from the experience.

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  Using Medical Device Symbols – ISO 15223-1:2021

  Explanation of changes in medical device symbols and practical implications as a result of the ISO 15223-1:2021 Symbols Update.

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  Regulatory Checklist

  The intent of this checklist is to aid self-assessment of your medical device commercialization readiness relating to regulatory requirements. Compare the answers you provide with stages from the StarFish Product Development Process at the end of the checklist to identify how ready you are for applicable regulatory requirements.

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  Pathways to a FDA Approved or Cleared Medical Device

  FDA Approved or Cleared Medical Device – the pathway you choose depends on the level of risk it represents and its intended use.

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  RoHS 2 vs RoHS 3 Impact on Medical Devices

  RoHS 3 (EU 2015/863) expands the list of prohibited substances from 6 to 10 adding 4 phthalates. Learn if your device is RoHS 3 compliant.

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  Why it pays to dig deeper – IEC 60601

  Medical Device Case study example where "dig deeper" – IEC 60601 saved the author from potential problems later down the road.

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  How to benefit from FDA ASCA (Accreditation Scheme for Conformity Assessment) Pilot Program

  FDA ASCA Pilot Program is expected to bring medical devices to patients and users more efficiently by using ASCA-accredited labs.

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  FDA Breakthrough Devices Program Update and Advantages

  How FDA Breakthrough Devices Program provides advantages for novel devices and can significantly reduce a product’s time to market.

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  COVID-19 Testing Authorizations in the US and Canada

  Overview of COVID-19 testing authorizations and developments of the COVID-19 pandemic in the United States and Canada.

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