Pharma Systems follow special quality assurance rules for the medical industry to make sure everything that leaves our production chain has the highest quality with quality controlls and testing on a daily basis.
There are no limits concerning Pharma Systems quality work. Each potential threat that could jeopardize or lead to negative changes in the quality of our products, quality of service or delivery need to be investigated and prevented.
Audited by Intertek
Pharma Systems is a certified according to:
- MDD 93/42/EEC – Annex II
- ISO 13485:2016 / MDSAP
- EN ISO 13485:2016
All Pharma Systems manufacturing sites are FDA registered
The quality system ensures that all applicable standards are strictly followed. These are Annex II of the directive 93/42/EEC on Medical Devices, ISO 13485, special quality assurance rules for the medical industry. Manufacturing facilities are inspected on regular basis by MDD Notified Body 0413 and Quality System Certification Body.To assure the outstanding quality of used materials and technologies, permanent testing and product development are needed. Our testing laboratory is equipped with devices that enable measuring a number of qualities, which are important for complete product evaluation.
Pharma Systems makes daily in-house tests to ensure quality and to find the best solutions for manufacturing and use of HME’s and Air filter media. For the filtration efficiency evaluation our laboratory uses TSI Certitest 8310, recommended according to standard EN 23328-1 (Breathing system filters for anesthetic and respiratory use –Part 1: Salt test method to assess filtration performance.)
The test rig for the HME effi ciency testing is built in accordance with ISO 9360 (Anesthetic and respiratory equipment – heat and moisture exchangers, HMEs for humidifying respired gases in humans – Part 1: HMEs for use with minimum tidal volumes of 250 ml) In addition to our own test laboratory other testing sources are used for independent evaluation.
