Clinical & Regulatory Archives

Clinical & Regulatory articles

Clinical & Regulatory

By The Engine Room

EU MDR: Are your labels compliant?

Do your homework to avoid a sticky situation, says Mark Cusworth, VP Research and Development, PRISYM ID. Here he examines the EU Medical Device Regulation and…

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Complex but helpful: negotiating FDA guidance to build a cybersecurity program

Clinical & Regulatory

By The Engine Room

Complex but helpful: negotiating FDA guidance to build a cybersecurity program

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By Tina Woods

Will we ever trust algorithms more than doctors?

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Clinical & Regulatory

By The Engine Room

Getting it right first time: reimagining the digital possibilities in the clinical laboratory

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A collaborative and ethical health tech ecosystem will thrive post-Brexit

Clinical & Regulatory

By The Engine Room

A collaborative and ethical health tech ecosystem will thrive post-Brexit

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Deal or no deal – manufacturers still need to comply with new EU medical device regs

Clinical & Regulatory

By The Engine Room

Deal or no deal – manufacturers still need to comply with new EU medical device regs

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Clinical & Regulatory

By The Engine Room

MDR: Market disruption on the horizon

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A fortunate opportunity? Navigating Chinese regulation challenges to ensure success

Clinical & Regulatory

By The Engine Room

A fortunate opportunity? Navigating Chinese regulation challenges to ensure success

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Don’t give me Brexit problems, give me Brexit scenarios

Clinical & Regulatory

By Medical Devices Legal

Don’t give me Brexit problems, give me Brexit scenarios

Don’t give me Brexit problems, give me Brexit scenarios At the moment I spend a considerable amount of my lawyering time answering questions concerning Brexit…

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