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What are the top medical device regulation priorities for 2023?

What are the top medical device regulation priorities for 2023?

by Mazur, B | Last updated Feb 11, 2023 | INSIGHTS, MEDICAL, REGULATORY

What are the top medical device regulation priorities for 2023? Reading time 11 mins Key Points Proposed UK healthcare reforms will impact the medical device regulation priorities for 2023 The Life Sciences Council’s joint statement on the future of the UK’s...
Why is medical interoperability important, and how is patient data protected?

Why is medical interoperability important, and how is patient data protected?

by Mazur, B | Last updated Mar 29, 2023 | ETHICS, INSIGHTS, MEDICAL, REGULATORY

Why is medical interoperability important, and how is patient data protected? Reading time 14 mins Key Points Medical interoperability is the ability of different computerised devices (e.g. personal care wearables, imaging devices, cardiac-implanted devices) to...
Conformity Assessment Marking: What kind of stamp does your device need?

Conformity Assessment Marking: What kind of stamp does your device need?

by Mazur, B | Last updated Mar 29, 2023 | Guides, INSIGHTS, MEDICAL, REGULATORY

Conformity Assessment Marking: What kind of stamp does your device need? Reading time 9 mins Key Points The UK leaving the EU led to changes in conformity assessment marking requirements. Changes and transitionary periods come into effect from July 2023 Manufacturers...
Will regulatory medical device reforms impact your quality management system?

Will regulatory medical device reforms impact your quality management system?

by Mazur, B | Last updated Feb 11, 2023 | INSIGHTS, MEDICAL, REGULATORY

Will regulatory medical device reforms impact your quality management system? Reading time 7 mins Key Points UK’s proposed regulatory medical device reforms (to improve patient safety and promote innovation) will be implemented in mid-2024 A quality management...
Free FMEA template download: Failure Modes and Effects Analysis

Free FMEA template download: Failure Modes and Effects Analysis

by Mazur, B | Last updated Mar 29, 2023 | INSIGHTS, MEDICAL, REGULATORY, TEMPLATES, TOOLS

Free FMEA template download: Failure Modes and Effects Analysis  Reading time 10 mins Key Points It’s a logical and structured way to identify and prioritise areas (i.e. failure modes) that could cause a process, product, or service to fail, hinder success, or cause...
What are the key regulatory challenges of Software as a Medical Device (SaMD)?

What are the key regulatory challenges of Software as a Medical Device (SaMD)?

by Mazur, B | Last updated Mar 29, 2023 | INSIGHTS, MEDICAL, REGULATORY, Software

What are the key regulatory challenges of Software as a Medical Device (SaMD)? Reading time 15 mins Key Points There is a lack of harmonisation between different regulatory bodies (e.g. FDA, MHRA, and EU MDR) as they define and categorise SaMD differently This changes...
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Recent Posts

  • A business startup costs template to help set you up for success
  • The Digital Health Revolution: How technology is transforming healthcare delivery
  • A competitor analysis template to fine-tune your unique selling points
  • How wearables detect diseases now and in the future
  • 5 top tips for designing wearable technology that stands out
  • Wearable tech for animals: An exciting new frontier
  • A product risk assessment template to help you identify safety hazards

Recent Posts

  • A business startup costs template to help set you up for success
  • The Digital Health Revolution: How technology is transforming healthcare delivery
  • A competitor analysis template to fine-tune your unique selling points
  • How wearables detect diseases now and in the future
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Put your innovation on autopilot. We help you develop technology to future proof your business and maintain your competitive edge for years to come.

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