Quality at ThermoGenesis
With over 20 years’ experience as a leader in manufacturing quality medical devices, ThermoGenesis Corp. has demonstrated its committed to quality. We strive to be a leading supplier of high quality and innovative medical devices and research products for advanced automated cell processing and biobanking, with the best customer service and support.
ThermoGenesis recognizes that the industry needs and regulatory requirements are constantly changing and therefore, we foster an environment of continual improvement in order to meet and exceed customer and industry expectations.
ThermoGenesis Quality Policy
At ThermoGenesis Corp., we are committed to meeting our customers’ expectations and requirements with high quality, reliable and safe products and services through open communication, effective processes, continuous improvement, and compliance with all applicable regulatory requirements.
The management at ThermoGenesis demonstrates its commitment to quality by establishing the company’s quality policy, goals, and objectives as well as a systematic reviews to ensure continual improvement.
Our Quality Management System (QMS)
ThermoGenesis has established a Quality Management System that complies with the applicable requirements of the EN ISO 13485: 2016 standard, the Food and Drug Administration’s Quality System Regulation (21 CFR Part 820), the European Union Medical Device Directive (93/42/EEC), the Canadian Medical Device Regulations (SOR 98-282), and/or other applicable local, state, national and international regulations. Quality is integrated into the entire product management lifecycle from design, development, manufacturing through ensuring our staff are trained to support all customer needs to internal auditing of all critical processes.
Registrations and Quality Certificates
- Quality Management System – ISO 13485:2016 #FM614123
- MDSAP Certificate #704865
- Quality Assurance System Certificate MDD 93/42/EEC Annex II #CE614420
- State of California Device Manufacturing License #98072
- FDA Establishment Registration # 2950374
- Contact us regarding registration status outside the USA
Quality is extremely important to us! If you have any quality questions, please contact Customer Support for more information.