Our manufacturing facility is ISO 13485 compliant and certified. We utilize a variety of quality tools and control systems to ensure we meet our customers’ quality needs and finished product specifications. From incoming raw material inspection to finished product release and validation testing, our quality personnel and integrated software systems control all aspects of the production process.
We offer complete design development planning, design reviews, and IQ, OQ, and PQ validations. We can generate design history files (DHFs), device master records (DMRs), and device history records (DHRs).
Contact Via Biomedical to learn more about our quality assurance.