QV Solutions

medical devices

About

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 [email protected] 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

Technologies

Gmail Google Apps Google Cloud Hosting

Keywords

medical device quality medical device software quality quality system regulation software validation regulatory submissions quality audits design history file remediation of dhf healthcare regulatory submission preparation medical device documentation consulting hipaa compliance data security risk assessment iso 9001 iso standards third-party reviewer regulatory strategy other scientific and technical consulting services cybersecurity in healthcare regulatory standards consulting medical device software fda submissions annex 11 medical device industry experience regulatory affairs b2b information security fda guidance

Location

San Diego, California, United States

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