OakRiver's quality system was developed concurrently with the launch of the Company. The founders of OakRiver recognized that a successful company is built upon consistency and predictable outcomes. This is especially true given OakRiver's participation in medical device and other high-tech industries.
The Company's quality system has been leveraged to help our medical device customers develop their validation protocols and supporting documentation. With growing regulatory requirements and increased demands on our customers' internal engineers, OakRiver has developed a suite of validation support services. These offerings include IQ/OQ/PQ protocol development, test protocol development, protocol execution and calibration.OakRiver's quality system and supporting processes are a competitive differentiator. We are proud of our quality system and customers have often told us that it is an integral part of the value we bring to the relationship.
OakRiver's Quality System is certified to the following standards:
ISO 9001:2008 Design & Manufacturing, Registration #FM 98980?Į
ISO 13485:2003 Medical Device Design & Manufacturing, Registration #FM 58109