Manufacturing

The Corin Group Companies maintain a comprehensive Quality Management System that is certified conforming with ISO 9001, ISO 13485, and meets FDA CFR 21§ 820 requirements. We are continually assessed by LRQA to assure the ongoing efficacy of the QMS and that the technical design files are appropriate for the devices we place on the market.

Quality Policy

Corin’s operations are underpinned by ensuring we all work to the ethos of our Quality Statement. This policy is supported by “quality objectives” that are routinely monitored, analysed and improved.

Process Control

At all stages of manufacture, the highest standards of precision, quality and hygiene are applied. To ensure that these standards are consistently achieved, the dedicated facilities house state-of-the-art CNC manufacturing systems and modern clean room suites.

Product Quality

Product Quality is at the forefront of our minds at Corin. All critical dimensions are 100% inspected on computer controlled measuring equipment prior to shipment. The data collected is used as one of the benchmarks against which we drive through further improvements.

Quality Management Team

Richard Sharp is the Regulatory Affairs Director and is responsible for directing all aspects of Regulatory and Clinical Affairs as well as Quality Assurance. Richard is supported by a highly qualified team of managers and engineers who oversee the day to day quality activities of Corin.

Clinical Affairs

The company is actively involved in the collation, analysis and reporting of clinical outcomes for its devices. The provision of this data to regulatory bodies and Surgeons is regarded as an important area of Corin’s activities in support of the advancement of evidence based orthopaedic surgery.

Quality Statement

Corin Group’s Quality Policy is to provide products and services that consistently satisfy the needs and expectations of both its direct and indirect Customers.

The level of quality shall be shaped by the business plan and delivered by processes that are robust, demonstrably reflecting our competences.

This policy will be achieved via the active involvement of all staff, with all being responsible for the effective management of their role within the team. All leaders will ensure that staff are trained and educated to support the delivery of quality.