Quality Assurance
Quality is the corner stone of Arrotek Medical. We understand the importance of using dependable suppliers, both in the quality of product supplied, and also in the quality of service provided. This is why everything we do at Arrotek medical is carried out under our ISO 13485:2003 accredited quality system.
Regulatory Services
Our experience of compiling and submitting for regulatory approval of Class II and Class III medical devices makes us the perfect partner to advise and road map the most efficient path to regulatory approval.
Regulatory services include:
- Process validations.
- Sterilisation validation.
- Age testing for shelf life.
- Transportation testing.
- Bench testing of transport and aging units.
- Clinical language verification for instruction for use.
- Testing to ISO standards.
- Label design.
- Sterilisation.
- File compilation and submissions for regulatory approval.
Quality Policy
Arrotek Medical designs, manufactures and delivers medical device products and components which meet or exceed the requirements of our customers in addition to satisfying our regulatory and environmental responsibilities.
Arrotek Medical management, staff and company as a unit are committed to ensuring compliance with the Quality Management System, regulatory requirements and to maintaining the effectiveness of this Quality Management System.
Arrotek Medical is committed to meeting all the requirements of the medical device industry in both a physical and ethical capacity.
The company will strive to continually improve its ability to consistently meet its commitments to customers, the environment and the needs and expectations of the medical profession while contributing to the medical welfare of the users of the products produced.
