Medical device quality management systems drive our high product standards
Adherence to quality and regulatory requirements is key to the successful supply of products to the pharmaceutical, medical and diagnostics industries. At Consort Medical we understand the interface between drug and device. We have a wealth of experience in working with customers to navigate the regulatory and quality pathway; from early stage through to full commercialisation.
Our quality assurance driven culture is based on continuous monitoring and improvement, where meeting the expectations of the customer is our highest priority. By complying with current regulations, we maintain the highest standards for our products over millions of devices every year.
The Operating Board has established the Consort Medical Quality Management System, conforming to ISO 13485, to ensure that everyone works to the same, consistent standards and intent. Our systems can be tailored to our customers’ specific needs to facilitate rapid transfer and commercialisation of high-quality product to market.
All of our sites meet international and local regulatory requirements
All of our sites have a strong track record of successful global regulatory inspections. We also have sites fully equipped and licenced to handle veterinary medicines and controlled drugs.
- EU GMP
- ISO13485:2016 accreditation
- US FDA
- Brazilian ANVISA
- Japanese PMDA
- Russian MOH
- South Korean SFDA
- Taiwan FDA
- Turkish MOH
- Belarus MOH
- Medical Device inspections by Notified Bodies