Microscope

EDINBURGH GENETICS

We pride ourselves on providing innovative and accessible in-vitro diagnostic and research reagents and devices with exceptional customer service to customers including academia, pharmaceutical companies, healthcare providers, and governmental organisations. Our products are used by millions of people globally.

To demonstrate our strong commitment to quality and user safety assurance, our quality management system governing the design and manufacture of our products is ISO 9001:2015, ISO 14001:2015 and ISO 13485:2016 certified and our products are manufactured at certified GMP sites, giving users the assurance that our products remain in compliance with regulatory requirements.

 
Science Student

QUALITY MANAGEMENT

ISO 13485:2016 

ISO 9001:2015 

ISO 14001:2015

Based on our management systems, we carry out regular internal audit and active market surveillance to monitor the implementation of our quality systems and verify that our medical and other products and services consistently meet customer requirements and applicable regulatory requirements. Records are kept to provide evidence of compliance with requirements and the effective functioning of the quality management system. Our quality management systems are implemented at all stages of the life cycle, including design and development, production, storage and distribution, with quality checks carried out at every stage.