Supplier & Quality Resources
Uncompromising Quality & Compliance Culture
Lives depend on the medical devices and precision components we design and manufacture. At Viant Medical, quality is not merely a operational standard—it is the core foundation of our global business strategy, corporate vision, and everyday operational culture.
Our global quality vision and rigorous compliance framework ensure consistent precision, full traceability, and risk control across every facility, project phase, and medical device lifecycle.
Committed to Patient Safety & Regulatory Compliance
Viant Medical is committed to delivering flawless medical components and finished devices that save and enhance patient lives. We rigorously adhere to international regulatory requirements, maintain dynamic ISO quality systems, continuous process validation, and active risk mitigation across our global footprint.
Regulatory Accreditations & Quality Systems
With over 50 years of specialized MedTech contract manufacturing experience, Viant provides global OEMs with expert navigation through complex regulatory environments and worldwide compliance mandates.
ISO 13485 & MDSAP Certified
Full ISO 13485:2016 certification and Medical Device Single Audit Program (MDSAP) approval across manufacturing facilities to support international market entry.
FDA Registered & cGMP Compliant
Fully compliant with FDA 21 CFR Part 820 Quality System Regulations (cGMP), supporting Class I, II, III, and combination devices, including PMA product launches.
ISO Class 7 & 8 Cleanrooms
Over 300,000 sq. ft. of certified ISO Class 7 and ISO Class 8 controlled cleanroom environments for sterile device molding, assembly, and packaging.
Advanced Quality Testing Labs
In-house metrology, microbiological testing, bioburden monitoring, and analytical material labs ensuring strict adherence to mechanical and biological tolerances.
Facility Tax & Regulatory Compliance Documentation
To streamline procurement, vendor setup, and financial governance for global healthcare OEMs, access site-specific W-9 and W-8 BEN-E documentation across Viant's global manufacturing footprint:
North American & International Tax Documentation (W-9 / W-8 BEN-E)
Instructions for Use (IFU) Reference Guides
Viant provides validated Instructions for Use (IFU) reference documentation for reusable orthopedic surgical instruments, reamers, handles, and impactors. Note: Paper IFU documentation is supplied with all physical devices; online entries are provided for regulatory verification reference.
Orthopedic Instrument Technical Reference Standards
Terms, Social Responsibility & Patents
Viant is committed to ethical supply chain practices, continuous environmental stewardship, and total intellectual property protection for OEM product innovations.
Partner with a Trusted Medical Device Quality Leader
Challenge us with your complex medical device manufacturing requirements. Our engineering and quality teams are ready to support your program from prototype through full-scale production.
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