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Iso 13485 Services
106 services found
by:Bureau Veritas North America, Inc. based inNew York, NEW YORK (USA)
Meeting legislative regulations and customer requirements for the manufacture and sale of medical devices in a global marketplace can be confusing. With so many regulations, differing from country to country, an organization must address a complex array of quality, process, and management issues in order to compete ...
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 ...
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 ...
Manufactured by:LaunchWorks CDMO based inBeverly, MASSACHUSETTS (USA)
ISO 13485 automated filling into microtubes, specimen tubes and bottles (up to 60 mLs). Volumes as low as 10 uLs. Filling capacity up to 500,000 units per ...
Manufactured by:Lumos Diagnostics based inSarasota, FLORIDA (USA)
Lumos has a world-class ISO 13485 certified OEM manufacturing facility, co-located with its technical R&D team to reduce the time and risk of transfer into production, and for ongoing ...
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 ...
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 ...
by:Circadia Health based in, PENNSYLVANIA (USA)
HIPAA compliant data management. ISO 13485:2016 quality management system. Class II Medical Device: FDA 510(k) ...
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:LaunchWorks CDMO based inBeverly, MASSACHUSETTS (USA)
With full traceability and product purity, our ISO-13485:2016 quality standards ensure all of your products are produced to your exact specifications including commonly overlooked items such as box label placement, component fulfillment into packaging or simply our critical eye for defects in raw ...
Manufactured by:AIV Inc. based inHarmans, MARYLAND (USA)
AIV repairs Lifecare 4100 infusion pumps models in its USA based ISO 13485:2016 certified facility. AIV's trained and experienced maintenance technicians perform specialized repairs to extend the life of your Lifecare 4100 infusion ...
Manufactured by:Lighthouse Imaging LLC based inWindham, MAINE (USA)
Lighthouse Imaging is the go-to contract manufacturer for medical optical devices. Leveraging our world-class facility, ISO 13485:2016 certified process, and decades of experience, we will bring your device to reality in our FDA registered ...
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:KSL Biomedical based inBuffalo, NEW YORK (USA)
KSL CRO Services team are well versed in quality compliance including requirements from ISO 13485:2016, 21 CFR Part 820 Quality System Regulation (QSR) and In Vitro Diagnostic Regulation (IVDR). KSL's team provides quality compliance services for start-ups and well-established companies looking to build out Quality Management System (QMS), maintain and improve ...
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: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:Aalto Scientific, Ltd. based inEatonton, GEORGIA (US) (USA)
In our 76,000 square foot, ISO 13485:2016 certified facility we have the necessary formulation vessels, mixing and filtration equipment, and manufacturing expertise to properly execute your existing product processes. We will interpret and convert your manufacturing processes into documents that comply with our quality system to ensure that the resulting product ...
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 ...