Quality
Zero Compromise
We exist to deliver products of exceptional quality.
Unwavering Commitment
Our dedicated, senior, and expert quality team collaborates closely with our customers to ensure the delivery of robust, reliable products that consistently excel.
We are deeply passionate about quality, underpinned by a rigorous quality management system, ISO certifications, and dedicated departments specialising in inspection, testing, and calibration. We maintain an unwavering commitment to zero quality failures.
- Fully certified – ISO 13485:2016 and ISO 14001:2015.
- FDA registered facility.
- Dedicated quality team across a huge range of functions.
- Robust, proven quality management system (QMS).
- 510(k) project submission support – complete documentation package preparation.
- Test method development, first article inspections, Gauge R&R.
- Internal LMS system for ongoing training and education.
Quality Functions
The team, processes and commitment to deliver quality products, every time.
- Calibration
- Metrology
- Process Validation
- Ensuring that our processes are consistent and repeatable, and that our critical products are finished to the highest standards or safety and efficacy. Our process validation includes installation qualification, operational qualification and performance qualification. Design Failure Mode and Effects Analysis is also employed to mitigate risk during product development.
- Incoming inspection
- Final release
Inspection & Testing Department
Precise, meticulous inspection and testing capabilities to ISO and ASTM standards, backed by continued investment in state-of-the-art inspection and testing equipment. Ensuring the safety, efficacy, and durability of our products.
- Material analysis
- Dimensional inspection
- Visual inspection
- Surface roughness testing
- Mechanical testing: Tensile, compression and fatigue testing
- Functional testing
- Statistical process control
Committed To Excellence
Croom Medical is committed to maintaining an effective quality management system to ensure compliance with all applicable quality and regulatory requirements, through continual improvement. We share a commitment to long lasting relationships based on trust, by partnering with our customers.
Fully Certified
