At all Hamilton Thorne companies commitment to quality and Good Manufacturing Practices are a way of life and essential to assist our customers in FDA inspections. Rigorous internal quality auditing maintains the highest level of production and quality control standards. Before shipping, every system is challenged by days of operations and exposure to extreme conditions. Our attention to good records and to detail is the foundation of reliability and of our proven track record in product quality.
- Hamilton Thorne, Inc. has been assessed and registered by the TUV SUD America Inc against the provisions of ISO 13485:2016 (Certificate #115799).
- Embryotech Laboartories (in Haverhill and Beverly MA) is an accredited ISO/IEC 17025:2005 Testing Facility
- Gynemed has obtained ISO certification for its line of medical devices and media:
- EN ISO 13485:2010 + AC:2012 (Number 6587DE438140709)
- Full Quality Assurance System Directive 93/42/EEC on Medical devices with CE Marking of Conformity (Number 2154875CE01)