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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 | Dec 29, 2022 | 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 | Dec 27, 2022 | 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 | Dec 22, 2022 | 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 | Dec 19, 2022 | 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 | Dec 15, 2022 | INSIGHTS, MEDICAL, REGULATORY

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 | Dec 13, 2022 | INSIGHTS, MEDICAL, REGULATORY

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

  • 5 tips for building a low-cost prototype & user-testing it 25th January 2023
  • Top 5 common product design mistakes and how to avoid them 24th January 2023
  • 6 common startup mistakes and how to avoid them 18th January 2023
  • What are the stages of designing a new product 16th January 2023
  • Why are B Corps gaining popularity, and should you get your company certified? 11th January 2023
  • 5 ways to improve your supply chain environmental, social governance impact in 2023 10th January 2023
  • Ignitec is close to becoming a carbon neutral company 4th January 2023
  • What makes Bristol an ideal base for green tech companies? 3rd January 2023
  • What are the top medical device regulation priorities for 2023? 29th December 2022
  • Why is medical interoperability important, and how is patient data protected? 27th December 2022
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