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Iso 13485 Services In Usa
57 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: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 ...
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: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: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: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: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: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:Gulf Fiberoptics based inOldsmar, FLORIDA (USA)
Gulf Fiberoptics can provide contract manufacturing services, engineering & design services, and dedicated production areas for your project. Gulf can provide the skills you need to focus on what really matters to your business. Gulf Fiberoptics is ISO 13485 certified and is a registered FDA manufacturing ...
Manufactured by:Resonetics based inNashua, NEW HAMPSHIRE (USA)
Our diverse technical experience and rapid-turn mindset will provide a creative force to drive the development of your next therapy. The Resonetics AGILE Product Development team is well-versed in ISO 13485 Design Control and ISO 14971 Risk Mitigation practices. We support your team while addressing engineering and manufacturing challenges at all ...
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:Domico Med-Device based inFenton, MICHIGAN (USA)
As an FDA-registered and ISO 13485:2016 certified medical device manufacturer, we manufacture products that meet all specifications and relevant regulatory requirements. Thanks to rigorous quality management throughout our manufacturing process, we build medical products that work as intended time and time ...
Manufactured by:Penlon Limited based inAbingdon, UNITED KINGDOM
PenlonCare starts with quality in-house design and manufacture, and flexibility of specification. Manufacturing systems at Penlon are certified to ISO 13485:2016 and all our products are CE marked. Penlon systems and facilities are regularly inspected and audited by the FDA, CSA, and other regulatory bodies. We consistently meet and exceed all the required levels ...
Manufactured by:AIV Inc. based inHarmans, MARYLAND (USA)
For over 30 years, AIV has been providing infusion pump repairs for many different types of IV pumps and syringe pumps in our ISO 13485:2016 certified facility. AIV repairs popular infusion pump brands including Baxter, Medfusion, Alaris, Hospira, and BBraun. ...
Manufactured by:Myriad Fiber Imaging Tech Inc. based inDudley, MASSACHUSETTS (USA)
The team at Myriad brings extensive expertise in the design, development, and manufacturing of medical devices, including ISO 13485 design controls and the ability to create a full DHF to support the regulatory filing process. Myriad has supported the Research & Development community for years by providing assemblies and sub-assemblies designed for ...
Manufactured by:Medisurge based inGrand Rapids, MICHIGAN (USA)
The medical devices we make have the potential to change patients’ lives. We take that responsibility very seriously. That’s why we’re ISO 13485:2016 certified and FDA Registered. We also hold a Japan Foreign Medical Device Manufacturing certificate. With MediSurge, you know your medical devices are in good hands. ...
Manufactured by:Cirtec Medical based inBrooklyn Park, MINNESOTA (USA)
With nine medical device facilities totaling nearly 400,000 sq. ft. of engineering, and production capabilities, including ISO 14644-1 Class 7 and Class 8 certified clean rooms, Cirtec can meet your needs, from pilot/clinical builds to full scale production. Our systems are ISO 13485:2016 or ISO 9001:2015 certified to ensure ...