Research, Development & Quality testing

Our R&D

Pharma System knows the importance of both research and quality. We have our own labs for both research and development aswell as for quality and testing. We make sure that we can deliver the very best products to the market that follows the medical industries strict rules.
We uses a quality system to ensures all applicable standards and our manufacturing facilities are inspected on regular basis:
- MDD 93/42/EEC – Annex II
- ISO 13485:2016 / MDSAP
- EN ISO 13485:2016
Research & Deveopment within HME/Filters

Research & Development

We on Pharma Systems know that continuous research and development is the key for new efficient and high quality end products.

We do extensive and thourough research on passive humidification for our Heat & Moisture Exchangers as well as develop the best filter efficency for our Bacterial/Viral filters so that they:

• Uses ISO standard ensuring safe connection security.
• Protects the patient from bacterial/viral contamination.
• Reduces the risk of cross-infection among patients and hospital staff.
• Less cleaning and decontamination of anaesthetic machines and ventilators.
• Initial set-up is simple, quick and secure.
• Different options ensure the right choice of device.
• Efficiency not affected by anesthetic agent.

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Quality Assurance for our HME/Filters

Quality & Testing

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.

We uses a quality system to ensures that all applicable standards according to Annex II of the directive 93/42/EEC on Medical Devices ISO 13485 are strictly followed. All our manufacturing facilities are also inspected on regular basis by MDD Notified Body 0413 and Quality System Certification Body.

To ensure the outstanding quality of used materials and technologies, permanent testing and quality controls are needed. Our testing laboratory is equipped with devices that enable to measure a number of qualities, which are important for complete product evaluation.
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Our distribution network

Pharma Systems are present in over 60 countries. Welcome to join our distribution family.
Apply here

Head office

Pharma Systems AB
Datavägen 5, 453 38 Lysekil
SWEDEN
+ 46 18 349500
info@pharmasys.se

Subsidary

Pharma Systems Eesti OÜ
Emmaste 92001, Emmaste vald
ESTONIA
+ 372 46 22460
info@pharmasys.se

Certificates

  • MDD 93/42/EEC – Annex II
  • ISO 13485:2016 / MDSAP
  • EN ISO 13485:2016
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