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
Company Details
- Employees
- 1
- Founded
- -
- Address
- San Diego, California, Us
- Industry
- Medical Device
- Website
- http://www.qvsolutions.info
- Keywords
- Medical Device Quality, Medical Device Software Quality, Quality System Regulation, Software Validation, Regulatory Submissions, Quality Audits, Design History File.
- HQ
- San Diego, California
Qv Solutions Questions
Qv Solutions's website is http://www.qvsolutions.info
Qv Solutions's LinkedIn profile is https://www.linkedin.com/company/qv-solutions
Qv Solutions has
1 employees.
View email and phone details for 1
employees at Qv Solutions.
Qv Solutions's industry is
Medical Device
Qv Solutions's top competitors are
Vitality Medical Products, Llc,
Medco Medical Management Inc,
Universal Medical Rentals And Equipment Sales Ii, Inc.,
Intelligent Medical Systems, Inc.,
Vas Training Academy,
Revito Labs Llc,
Chandelier Medical,
Happ Medical,
Iris Medical Equipment, Llc,
Red Group International.
Qv Solutions's categories are Medical Device
Qv Solutions's founding year is 2020
