QV Solutions

Medical Device Consulting Services. -Subject Matter Experts in Medical Device Software Quality and Compliance. -20+ years of medical device industry experience including working with the US FDA as accredited third-party 510K reviewer. Contact us at bgurevich@qvsolutions.info Specializing in five core areas: 1. Creation, Assessment or Remediation of Design History File (DHF) per CFR 820, ISO 13485, applicable FDA Guidance documents, IEC 62304, ISO 14971 and more 2. Creation, Assessment or Remediation of Quality Management System (QMS) per CFR 820, ISO 13485, ISO 9001 and more 3. Preparation of Regulatory Submissions to US FDA (e.g., 510K, IDE, PMA) or EU MDR/IVDR per applicable guidance documents and recognized consensus standards 4. Quality System Software Validation per CFR 820.70, 21 CFR - Part 11, FDA General Principles of Software Validation, AAMI/ISO TIR80002-2, GAMP5, Annex 11 5. Data Privacy, Information and Cybersecurity per HIPAA, GDPR, applicable FDA Guidance documents, recognized consensus standards and more