About Us
ISO 13485
We put rigorous quality management at the centre of everything we do, providing our clients with compliance to standards for safety, quality, risk management and traceability.
The significant benefits of ISO 13485 certification 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
ISO 13485 Requirements
Any medical device or IVD placed on the market must comply with the relevant classifications:
- USA: compliance and approval to FDA regulations for Medical devices:21CFR.
- Europe: MDR and IVDR requirements
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.
