Services
General
Medical & Pharmaceutical
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International registrations: US FDA, EU CE Mark, Canada, Japan MHLW, China SFDA, Australia TGA
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Safety marks: UL, CSA, TUV, ETL Intertek, MET Labs
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Design Control & Risk Management
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Usability & Human Factor Evaluation
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Verification & Validation
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Software Life Cycle & 21 CFR Part
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Controlled Environment and Cleanrooms
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Sterilization and Aseptic process
Our mission
Quality assurance and regulatory affairs, including Comprehensive a-z compliance project management.
Industry leaders in regulatory and compliance projects.
Proven record of successful and cost-effective solutions for innovative products and challenging markets.
Experienced group of experts available for quick integration in multidisciplinary development teams.
Company
We believe in flexibility of work models, adapting to customers specific needs
ELV QA & RA Solutions Ltd. delivers above 20 years of experience in assisting customers with their quality assurance, regulatory affairs and product compliance projects. Focused on the Pharmaceutical, Medical Device and In-Vitro Diagnostic (IVD) industries, our motivated and highly trained experts provide the knowledge and competence necessary in leading the way through demanding international compliance requirements.