The chemical manufacturer and packaging company has achieved ISO 13485 accreditation for medical devices
ReAgent Chemical Services has achieved ISO 13485 accreditation, effective 8 August 2019.
A UK-based company headquartered in Chesire, ReAgent's latest international ISO standard demonstrates the company meets the rigorous requirements of a quality management system specific to the medical devices industry.
ISO 13485 is a practical foundation and solution to meeting Medical Device Directives, regulations, and responsibilities.
Companies accredited to this standard show that they are committed to the safety and quality of medical devices, and demonstrate their ability to provide medical devices and related services that constantly meet customer and relevant regulatory requirements.
For ReAgent, this means they are accredited to supply bespoke biological reagents for use in medical devices.
“Gaining ISO 13485 accreditation is a great achievement for ReAgent," said Richard Hudson, ReAgent CEO. "It shows our high-quality standards, provides credibility to our customers and adds another string to our bow. I’m very proud of the team, who are committed to making ReAgent the best it can be for our customers,” he concluded.
Alongside this accreditation, ReAgent has also launched a new biological reagent manufacturing service supplying bespoke reagents, including biological buffers, bioprocessing reagents, and in vitro diagnostic reagents.
With the ability to manufacture different types of biological reagents, including, but not limited to reagents for use in medical devices, ReAgent’s customers will have the peace of mind that the manufacturing processes and controls ReAgent has in place are rigorously quality-controlled and compliant.
The company said customers can be confident that ReAgent is a credible, trustworthy manufacturer of bespoke biological reagents.