• 

  Medical Device Labeling Requirements: Compliance and Best Practices

  We all know medical devices have labels, but how often do we consider their purpose and the effort required to ensure they provide the right information? Device labelling serves as the interface between the manufacturer, the user, and regulatory bodies. (Note that being from Canada, we spell labelling with two Ls.)

• 

  Using The FDA’s Best Practices for Selecting a Predicate Device

  Review of the FDA Selecting a Predicate Device to Support a 510(k) Submission Draft Guidance on Best Practices

• 

  UK Medical Device Brexit Implications

  Summary of UK Medical Device Brexit Implications including high-level key points of the MHRA post-Brexit implementation plan.

• 

  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.

• 

  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.

• 

  7 Outcomes to Watch from Health Canada’s Action Plan on Medical Devices

  7 interesting outcomes of the 2019 Health Canada Action Plan on Medical Devices initiatives and alignment with international regulators.

• 

  Is the FDA Early Feasibility Studies Program right for you?

  FDA’s Early Feasibility Studies Program (EFS) is a great option in early stage development looking to advance your program by gathering data.

• 

  How to address medical device cyber attacks

  Any medical device connected to a hospital network or the cloud may be exposed to some form of medical device cyber attack.

There are no posts to show