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...
by Mazur, B | Last updated Jun 12, 2023 | HEALTH, INSIGHTS, IoT, REGULATORY
Is my product a UK medical device? Reading time 8 mins Key Points The WHO estimates that there are currently 2 million types of medical devices on the world market The Healthcare products Regulatory Agency (MHRA) is the executive agency that oversees the regulation of...