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United Kingdom

TECHNOLOGY AND PRODUCTION

Cutting-edge biomechanical industry technologies are used to make top-class products: the sophisticated production facilities currently make use of 8 machines for automatic linear and rotating quality control and of a metrological laboratory for calibrating high-precision instruments able to ensure measurement precision reproducibility.
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An automated sandblasting and acid-etching plants permit the accurate control of implant surface roughening and passivation processes; this way macro and micro surface roughness is ensured.
For product assembly and packaging, in an environment with controlled levels of purity, a large clean room has been set up which ensures decontamination in inert gas plasma reactor and double packaging under laminar flow extraction hoods in class 100.

QUALITY AND CERTIFICATIONS

We work according to a quality control system in conformity with UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards dedicated to medical devices, in compliance with Directive 93/42 and MDR 2017/745 on Medical Devices. Sweden & Martina have met quality systems for FDA as current good manufacturing practices (CGMP’s).

THE QUEST FOR QUALITY, BOTH AS REGARDS PRODUCTION, ORGANIZATION AND SERVICES PROVIDED, IS STRATEGIC FOR THE COMPANY, AS WELL AS A KEY FACTOR BEHIND ITS SUCCESS.

Sweden & Martina Implant Systems are registered in Albania, Baltic Republics, Bulgaria, Czech Republic, France, Germany, Great Britain, India, Iran, Italy, Japan, Jordan, Mexico, Perù, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia-Croatia-Bosnia, Spain, Switzerland, The Netherlands, United Arab Emirates, Ukraine, USA.




The mechanical functions of the implants are tested in accordance with the rigorous prescriptions ISO, FDA, PMDA, CE, MHRA, with structural calculation tests of the FEM (Finite Element Analysis) type and with static and dynamic strength tests.

All systems are successfully tested at 5,000,000 cycles to determine their response to fatigue, according to standards, and comply with extremely stringent acceptability criteria and parameters.
   
ISO 45001:2018 - HEALTH AND SAFETY AT WORK
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CE CERTIFICATE - SYSTEM QUALITY ASSURANCE
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ISO 9001:2015
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ISO 13485:2016
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QUALITY POLICY
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QUALITÄTSPOLITIK
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POLITIQUE DE QUALITÉ
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