Operations, Quality Assurance & Regulatory Affairs

Orthodynamics has a sophisticated manufacturing facility to meet the demands and requirements of the orthopaedic market. It has an on-site dedicated cleanroom, which ensures control of the microbiological contamination. Good Manufacturing Practice (G.M.P) compliance is at the heart of our manufacturing and logistics philosophies.

Extensive product evaluation procedures aim to guarantee confidence in our products and customer satisfaction. We only select suppliers and sub-contractors who meet our stringent purchasing and quality requirements.

Orthodynamics is committed to the principles of Total Quality Management, with an integrated Quality Management System which is compliant to the requirements of recognised International Standards and which is continually developed, audited and reviewed.

All products are in compliance with the European Medical Device Directive 93/42/EEC for CE-Marking.

All our products are monitored throughout all stages of development, procurement and manufacture to ensure that conformance to specification is achieved.

Orthodynamics has the capacity to be able to provide design and manufacturing capabilities as a subcontractor for other companies that may not have the capacity.