ISO 14155 A Complete Guide - 2021 Edition

Are there patents on products or technologies that are very similar to your product/idea?

Do clinical incident investigation practices reflect the principles of systems thinking?

Does the medical device show any signs of wear, damage or faults that should be reported?

Have you seen a medical professional using a mobile device during treatment or diagnosis?

How do you effectively navigate all of regulations and effectively maintain compliance?

How will the incorporation of AI into products affect the relevant regulatory approaches?

Is a class of medical devices or medical equipment generally the subject of the record?

Is the pre market assessment of medical devices considered overly complex in other ways?

What is the transitional provision relating to the conduct of a clinical investigation?

Who is responsible for protecting the confidentiality of the subjects private information?

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Unless you're talking a one-time, single-use project, there should be a process. That process needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

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