ISO 13485 is the unequivocal gold standard for quality in the medical device industry.
As a leading supplier to the medical device industry for precision metal stamping, CNC-machining, and advanced manufacturing expertise, meeting the requirements for our ISO 13485 Certification further fortifies Hobson & Motzer’s commitment to the medical device market to maintain excellence and the highest quality components. This ISO 13485 Certification enhances the foundation of an already robust quality management system (QMS): ISO 9001:2015, which has been in place since 1996, to ensure Hobson & Motzer customers that quality—in every aspect—is systemic and reliable. We had been certified to IATF 16949 and were already producing at a very high standard; ISO 13485 aligns better with our core business focus in the medical device space.
ISO 13485 is designed to be used by organizations involved in one or more stages of the medical device lifecycle: design and development, production, and storage.
The framework for implementation includes:
- Outlining how to review and improve processes
- Increasing efficiency, cutting costs, and monitoring performance
- Demonstrating the production of safer medical devices
- Meeting regulatory requirements and customer expectations
Our adherence to ISO 13485 provides a deeper assurance to the medical device industry and to patients around the world who benefit from these critical products that we remain a dependable supplier, upholding the highest quality and precision standards.