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...
by Mazur, B | Last updated Aug 4, 2023 | HEALTH, INSIGHTS, REGULATORY
What is ISO 13485? Is it mandatory for medical device compliance? Reading time 7 mins Key Points ISO 13485 is an international standard which specifies the requirements for quality management systems (QMS) for the design, production, installation, and servicing of...
by Mazur, B | Last updated Jun 12, 2023 | HEALTH, INSIGHTS, REGULATORY
How does UK MDR (Medical Device Regulations) differ from EU MDR? Reading time 8 mins Key Points All medical devices placed on the Great Britain market (England, Scotland, Wales) need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA)...
by Mazur, B | Last updated Jun 12, 2023 | Guides, HEALTH, INSIGHTS, REGULATORY
UK Medical Device Regulations (MDR) Glossary: What every medical device engineer should know Reading time 12 mins Key Points As demand for healthcare technologies increases, rushing to get products to the market by cutting corners can have serious consequences UK...