Quality Assurance & Regulatory
Smiths Medical OEM is fully compliant with all applicable FDA, ISO and EN Standards governing its industry.
- ISO 13485:1996, Certified
- ISO 13485:2003, Certified
- FDA QSR (Quality System Regulation) Design and Development Controls
Design Controls and Manufacturing Practice
Smiths Medical can participate in every stage of the development cycle to support your product development needs. We comply with FDA and ISO requirements of Implantable and Non-Implantable Medical Devices.
Our quality is of the highest level in our industry. Product and environmental records are maintained.