To achieve our Quality Objective, we are making three fundamental commitments to our customers, our employees and the environment in which we are growing.
Since its creation, Teknimed has been committed to a quality approach enabling it to ensure the performance and safety of its products.
Our quality system has been certified since 1996; it is based on a strategy of continuous improvement and meets national and international requirements, particularly through:
- benchmark standards ISO 13485, CFR 21 part 820 and MDSAP
- compliance with current regulations (particularly FDA and European Directive 93/42/EEC),
- audits by our notified body and by our customers,
- ANSM, ANVISA, KFDA, FDA – 21 CFR Part 820 inspections.
To guarantee the safety of our products, our resources include the following:
- supply chain management (particularly supplier audit),
- document system providing full traceability of medical devices,
- efficient quality control laboratory,
- process validation subject to a validation master plan complying with 21 CFR part. 820 (IQ, OQ, PQ),
- staff training (GMP),
- product sterility, by controlling the production environment (qualification & monitoring) and by validating sterilisation processes.
We are committed to offering our customers and prescribers high quality products and services:
- by using our customer services department to take their expectations into account and by providing fast, appropriate responses,
- by working continually to optimise our production and distribution systems, to ensure the quality and constant availability of our products,
- by reducing deadlines for Management of Corrective Actions and Preventive Actions (CAPAs).