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Iso 13485 Services In Europe
70 services found
by:NSAI Inc. based inNashua, NEW HAMPSHIRE (USA)
ISO 13485 is a necessary certification for medical device manufacturers. It proves that you have a quality manufacturing process and the management standards in place to maintain high quality. ISO 13485 certification is the first step towards achieving compliance with European, Canadian and other regulatory requirements for ...
Manufactured by:Anton Hipp GmbH based inFridingen an der Donau, GERMANY
CERTIFICATION ACCORDING TO DIN ISO 13485. Every year we prove our ability and dedication to high quality. With the certification according to DIN ISO 13485 we meet the highest quality standards. Through a further certification according to Annex 2, we are also able to manufacture disposable products and implants that meet the ...
Manufactured by:Aristotech Industries GmbH based inLuckenwalde, GERMANY
Applying the latest forging technology with validated processes. Highest standards ISO 13485 as well as FDA requirements Aristotech forgings guarantee A net–shape premium ...
by:Emperra GmbH E-Health Technologies based inPotsdam, GERMANY
To verify and constantly improve the quality and safety of ESYSTA products, Emperra GmbH has a certified quality management system in place that complies with DIN EN ISO ...
by:CIGA Healthcare Ltd based inBallymena, UNITED KINGDOM
All our devices are manufactured under ISO 13485 Quality Management Standards to ensure that our products are manufactured to the highest quality & standards we feel our customers should ...
Manufactured by:G.Samaras S.A. based inThessaloniki, GREECE
G. SAMARAS S.A. is verified according to EN ISO 9001 and ISO 13485 in the field of Medical Gases installations. The installation operations are executed by specialized personnel ensuring the right installation and compliance to the International ...
by:Neuromod Devices Limited based inDublin, IRELAND
Neuromod maintains a certified Quality Management System to ensure compliance to the applicable regulations in regions that it distributes its devices. Neuromod’s Quality System Certificate ISO 13485: 2016. Neuromod’s CE Certificate Full Quality Assurance. ...
by:SCREENTEC based inOulu, FINLAND
Our ISO 13485 and certification supports our growth as a contact manufacturer of medical devices and ...
Manufactured by:Mona Lisa N.V. based inHerk-de-Stad, BELGIUM
Due to its longyear experiences Mona Lisa N.V. offers consultation and support in all questions concerning: Quality management (ISO 13485:2016), Technical files for all CE products of class II, III, Technical drawings for special moulds of medical ...
Manufactured by:Steris Instrument Management Services based inDerby, UNITED KINGDOM
With over 4000 surgical instruments to choose from, our extensive product range offers clinicians absolute peace of mind with a 25 year guarantee. All our instruments are manufactured to the highest standards adhering to ISO ...
Manufactured by:Delmont Imaging based inParis, FRANCE
Delmont imaging has since day one, focused on delivering highest quality products with full CE certification (MDD 93/42) and good manufacturing practice certification ISO 13485:2016. Our products are now registered in more that 50 countries across the world and this number is continuously growing. ...
Manufactured by:APTEC Diagnostics nv based inSint-Niklaas, BELGIUM
In-house training facilities • Extensive list of application notes for currently available instruments • CE-marked products • ISO 9001:2008 and ISO 13485:2003 certified • Anvisa Certified N° 349556/10-6 • Application approval on customer’s and/or in-house ...
Manufactured by:Althena Medical based inCittà sant’Angelo (PE), ITALY
Our quality system is ISO 13485:2016 certified. However, our internal controls go far beyond the obligations of our ...
Manufactured by:Prima Lab SA based inBalerna, SWITZERLAND
We have great flexibility in response to peaks in demand, both internal and external, thanks to different production lines. Our devices are manufactured according to the high standards of the Quality Management System, ISO 9001:2015 and ISO 13485:2016 and are equipped with CE Certification, issued by the German Notification Body MDC. ...
Manufactured by:Tende Electronics Software Engineering Communication Machinery Industry and Trade Ltd. Şti. based inSincan, TURKEY
TENDE Products are designed by the Tende engineers, for maximum efficiency, safety, and durability. Tende has CE, ISO 13485:2003 and ISO 9001: 2008 Quality Management System. Tende products have been produced in a modular structure. Genuine parts should be used for repairment by Tende authorized people. By doing this way the efficiency of the ...
Distributed by:Bio Sud Medical System srl based inModugno (BA), ITALY
The BIO SUD MEDICAL SYSTEMS Ltd is ISO 13485 and ISO 9001 by DNV GL, ensuring responsible management of the products and services provided in the medical field. The adoption of the Quality Management System constitutes a strategic decision of the organization that needs to show the company's ability to provide its customers, with regularity, ...
Manufactured by:Prodromus S.A. based inKraków, POLAND
The Prodromus company is a certified service of medical devices in compliance with ISO 13485. We have the necessary equipment and the competence to carry out measurements of electrical medical devices in compliance with ISO 60601 and EN 62353. We invite you to cooperate in the provision of services in both measurement and in the implementation of ...
Manufactured by:SHL Medical AG based inZug, SWITZERLAND
SHL implements quality management systems throughout all phases of development and production to ensure consistency in all products. SHL’s quality system complies with FDA Quality System Regulation, Medical Device Regulation, and ISO 13485:2016. The system is regularly audited by customers and monitored internally through stringent ...
Manufactured by:Integra MicroFrance based in, FRANCE
MicroFrance instruments meet European regulatory requirements for medical devices, materialised by the affixing of the CE marking. Furthermore, we have NF EN ISO 13485:2016 and MDSAP for the activities of design, manufacturing, inspection, and marketing of active and non-active instruments, including electrosurgical instruments. These certificates also cover ...
Manufactured by:Roesys MedTec GmbH based inEspelkamp, GERMANY
With modern aids such as CAQ software, it is ensured at all times that every employee has the latest information on the quality management system available at all times. The quality management of Roesys MedTec GmbH is certified according to the international standard DIN EN ISO 13485:2016. Furthermore, the products of Roesys MedTec GmbH are approved in several ...