ELV is a privately-owned consulting and project management company. We provide Quality, Regulatory Affairs and Product Compliance services. The agency has three independent market divisions –Medical, Civil and Military.
Our main business is streamlining the product release processes for our customers and helping them to bring the product to market with best ROI and shortest time. We define the compliance strategy, that harmonises between the timelines and cost effectiveness constrains, regulatory requirements and quality aspects.
Our activities cover Regulatory Affairs (FCC, FDA, CE mark etc.), technical standards (EMC, Radio, Product Safety and Environmental requirements) and Quality Management System (ISO, Design Control, Verification & Validation, ERP system planning etc.)
Who can use our services?
• Start-up companies in the early development stages, facing statutory requirements for the first time.
• Companies looking for a shorter time to market and for better product launch approaches.
• Regulatory and compliance leaders of major enterprises, seeking the single expert point to outsource a part of their activities.
Company’s Keywords:
emc, product safety, environmental, information systems, radio, nrtl factory inspection, iso, risk management, usability, design control, fda, ce mark, fcc, verication, validation, software life cycle & 21 cfr part 11, sterilization & aseptic processes
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