by Mazur, B | Last updated Aug 8, 2023 | HEALTH, INSIGHTS, 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...
by Mazur, B | Last updated Jun 12, 2023 | ETHICS, HEALTH, INSIGHTS, 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...
by Mazur, B | Last updated Aug 8, 2023 | Guides, HEALTH, INSIGHTS, 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...
by Mazur, B | Last updated Jun 12, 2023 | HEALTH, INSIGHTS, 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...
by Mazur, B | Last updated Aug 1, 2023 | HEALTH, INSIGHTS, 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...
by Mazur, B | Last updated Jun 12, 2023 | HEALTH, INSIGHTS, 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...
