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Iso 13485 Services In Usa California
6 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 ...
by:NOVO Engineering based inVista, CALIFORNIA (USA)
NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO 13485:2016-certified quality management system (QMS) covers a five-phase product development process (PDP) from concept through manufacturing transfer, including support for clinical trials and regulatory submissions. Our medical ...
Manufactured by:IVD Research, Inc. based inCarlsbad, CALIFORNIA (USA)
Our custom-tailored contract manufacturing services provide complete turnkey solutions for all of your product commercialization needs, from start to finish. We treat our customers’ products like our own, ensuring the highest quality and quick response times to get your product to market ...
Manufactured by:Advanced Endoscopy Devices, Inc. (AED.MD) based inCanoga Park, CALIFORNIA (USA)
Since 1985, AED has been providing our customers with the finest endoscopes, endoscopic instruments, and repair services. Our European factory trained technicians have over 200 years of combined experience in endoscopic manufacturing and repair. We guarantee your complete satisfaction, competitive pricing, superior quality, and premier capabilities. We provide expert repair services for all makes ...
Manufactured by:BioCheck, Inc. based inSouth San Francisco, CALIFORNIA (USA)
BioCheck provides a variety of services including: Custom Immunoassay Development, ELISA, Ultrasensitive Immunoassays using Simoa (single molecule array) Technology, Antibody Purification and Conjugation, Contract Manufacturing and ...
by:STEMart based inShirley, CALIFORNIA (USA)
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC, which outline the safety and performance ...