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Iso 13485 Medical Device Services In Europe
9 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 ...
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 ...
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 ...
Manufactured by:Eonex d.o.o. based inTrnovec Bartolovecki, CROATIA
In order to identify and address design and engineering flaws in the early stage, we use rapid prototyping technology with 3D printers. The main benefit of this method is quick and cost-effective prototype development, enabling us to identify any deficiencies in the design during the product development phase. In this way, new potential solutions are generated. By selecting the optimal solutions, ...
Manufactured by:Komet Medical based inLemgo, GERMANY
With our extensive experience in the medical technology industry, you can rely on our expertise, compliance, and quality for your medical ...
Manufactured by:Visia Lab Srl based inSan Giovanni Valdarno, ITALY
Our product design and development services provide our customers with a single point of responsibility throughout the entire product making process. ...
Manufactured by:Visia Lab Srl based inSan Giovanni Valdarno, ITALY
Our product design and development services provide our customers with a single point of responsibility throughout the entire product making process. Based on the foundation of ISO 13485 for IVD medical devices, our manufacturing team offers flexibility, expertise in laboratory diagnostics and device ...
Manufactured by:LRE Medical based inNoerdlingen, GERMANY
Always conscientious and quality-conscious: We completely meet our customers’ needs by providing them tailor-made solutions, designed and engineered to always be compliant with regulatory standards. In our fullservice approach that extends from the initial idea to the finished, validated diagnostic device produced in series, we exhibit utmost flexibility. This includes flexible project ...
by:Metecon GmbH based inMannheim, GERMANY
An audit is the most effective method to establish certainty that you as the manufacturer or distributor of medical devices are in the position to meet all requirements. Metecon offers comprehensive support in this regard with a wealth of experience and know-how. Take a moment to get an overview of our services. And if you see any need, we look forward to discussing a solution with ...
