Any medical device or IVD placed on the European market must comply with the relevant classification MDR and IVDR requirements or in the US compliance and approval to FDA regulations for Medical devices:21CFR.
Product and user safety are critical for medical device compliance. ISO 13485 specifies requirements for a quality management system which can demonstrate a company’s ability to design and manufacture medical devices & IVDs that consistently meet applicable regulatory requirements and customer specifications.
The significant benefits of ISO 13485 for our clients are:
- It ensures consistency in what we do
- It identifies ways to constantly measure and improve
- It enables a risk-based approach
- It supports our customers confidence and satisfaction
- It demonstrates evidence of compliance with applicable regulations for safety and performance
For more information about how ISO 13485 supports our medical device design services, please contact us.
What our clients say...
"It is a pleasure to work with the team at eg technology and I have been impressed by their understanding of the project concept, the needs and the implementation of a practical solution."
"We were very impressed with eg’s innovative and creative approach to solving complexities around the design and functionality of the IMOD®. We were extremely happy with the end product and look forward to working with eg technology in the future.”