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Iso 13485 Services
134 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 ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
HingeClinica is a world class partner for Medical Device services. We render End to End Medical device MDR compliance and Regulatory services, Clinical trial, Pharmacovigilance services to Medical Devices industry. Our Medical Device team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, regulatory Submissions and ...
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 ...
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 ...
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 ...
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: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: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: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 ...