Providing high-quality products and services has always been a primary goal for Medicon.
Our initial efforts focused on implementing and maintaining Good Laboratory Practices (GLP's) in production, a set of rules that later developed into Good Manufacturing Practices (GMP's) aligned with those in the Pharmaceutical Industry.
Medicon implements procedures for fully complying with the requirements of the IVDD (Directive 98/79 EC) governing production and distribution of diagnostic products in the European Union. Each batch of reagents we produce is thoroughly controlled, both during the various stages of the production process and during the reagent's shelf life and beyond. Complete QC/QA files are kept and are available to all interested parties with all testing and statistical data for each production lot and a thorough vigilance system is in place according to the Directive 98/79 EC.
As part of our vigilance program, the smallest performance deviation of any reagent from its specification is immediately notified to the company management that takes the necessary corrective measures (customer briefing, analysis protocol correction, withdrawal, etc.) to ensure safe operation continuation of our customer laboratories.
Medicon is the only Greek diagnostic company to operate under license by the National Medicines Agency (EOF), the Competent Authority for Diagnostics in our country.
- EN ISO 9001:2015
- EN ISO 13485:2016
- EN ISO 14001
- CE according to the Directive 98/79 / EC
- License for production by the EOF
- Ministry of Health Decision E3 / 833 / 22-6-99
- Permit for operating-handling of animal by-products in accordance with Regulation 1774/2002 / EC
- 510 (K) approval from the FDA for a range of products.