Stringent requirements require an experienced partner.
The complex healthcare and medical landscape is adapting and changing constantly. The welcome introduction of new medical device regulations indicates one of the most significant developments within medical device manufacturing for a number of years. While this aims to address some medical device related issues, the sector as a whole faces several other significant challenges, many of which are centered around keeping patients safe and protecting their information in a period where technology continues to advance.
LRQA offers a range of services to organizations operating within the medical devices industry including:
- ISO 13485 accredited certification
- ISO 13485 training courses
- MDSAP certification
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How we can help
We apply our expert solutions and independence to assure the integrity, reliability and success of every aspect of your operation. Helping maximise productivity and recovery, reduce operating costs, mitigate risk and demonstrate compliance with government regulations, industry codes and standards, many of which we have helped to develop.
Who we work with
We help businesses across dozens of sectors push forward and achieve like never before. How can we help you?
ezCaretech: protecting patient data in South Korea.
LRQA assessed ezCaretech against ISO 27001 and CSA STAR, which demonstrates that the company’s cloud computing networks effectively manage security.
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9 Dec 21
IEMA Connect 2021
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10 Feb 22
Food Safety Europe 2022