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...
"eg technology’s work was instrumental in automating the Parsortix system so that patient blood can be processed efficiently using ANGLE’s patented Parsortix technology to capture CTCs. This was a major step forward in bringing the Parsortix technology to market."
"It is never easy to integrate the conflicting requirements of biochemistry, electrochemistry and engineering in any project, but I was very impressed with the breadth of capabilities eg technology brought to the project. Close integration with the team here at Vantix led to a smooth and efficient interface."