QV Solutions -
True Quality
Subject Matter Experts in Medical Device Software Quality and Compliance
50+ combined years of medical device industry experience including working with the US FDA as accredited third-party 510K reviewer
Regulatory and Compliance Services
We Are Specializing in Seven Core Areas
- Creation, Assessment or Remediation of Design History File (DHF) per CFR 820, ISO 13485, applicable FDA Guidance documents, IEC 62304, ISO 14971 and more.
- Creation, Assessment or Remediation of Quality Management System (QMS) per CFR 820, ISO 13485, ISO 9001 and more.
- Preparation of Regulatory Submissions to US FDA (e.g., 510K, IDE, PMA) or EU MDR/IVDR per applicable guidance documents and recognized consensus standards.
- Planning and Execution of Quality System Software Validation per CFR 820.70
- Compliance with 21 CFR Part 11, FDA General Principles of Software Validation, AAMI/ISO TIR80002-2, GAMP5, Annex 11.
- Establishment of Risk Management framework per ISO 14971 including AI/ML and cybersecurity related risks.
- Establishment of Data Privacy, Information Security and Cybersecurity Controls per HIPAA, GDPR, applicable FDA Guidance documents, recognized consensus standards and more.
Contact Us
FAQ
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WHAT ARE THE REQUIREMENTS FOR FDA 510K CLEARANCE?Simply put to obtain an FDA 510(k) clearance, a medical device must demonstrate that it is substantially equivalent to a legally marketed device. That device is called a predicate device. The electronic Submission Template And Resource (eSTAR) is an interactive PDF form that guides applicants through the process of preparing a medical device submission. All 510K submissions must use this format.
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HOW LONG DOES IT TAKE TO OBTAIN FDA 510K CLEARANCE?The FDA’s 510(k) clearance process for medical devices typically takes around five to six months, but the time frame can vary depending on the quality of the documentation.
About
QV Solutions provides comprehensive Regulatory Affairs and Compliance services to the the medical device companies seeking regulatory approval.
QV solutions's Regulatory Affairs and compliance services consultants enable medical devices companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements to successfully launch their products.
Services and features include advising on Quality Management System and Design History File creation, gap assessment and remediation, supplier qualification, audit support, preparation of Regulatory Submissions to US FDA and/or EU MDR/IVDR
Testimonials
Boris's expertise in the medical device regulatory landscape helped our clients to meet all the requirements and facilitated regulatory approval of their devices. He was able to provide clear and concise guidance on all aspects of quality, from risk management and design control to quality system implementation and regulatory submissions. Also, he led third-party 510K reviews and communicated directly with the FDA to get assistance and feedback. I highly recommend Boris to anyone seeking a qualified and experienced medical device quality consultant.
Having Boris as a consultant has significantly accelerated Nanostics’ journey toward regulatory compliance. He’s knowledgeable with international standards and FDA guidance for medical device software and provides practical advice for meeting regulatory requirements.
Robert Paproski
Chief Technology Officer
Nanostics, Inc.
Shawnnah Monterrey
CEO, Beanstock Ventures
Team Members Bio
Boris Gurevich
CEO and Founder
Boris Gurevich founded QV Solutions following a 25-year career as technical leader in both startups and mature medical device companies, Boris is a Certified Software Quality Engineer and Quality Auditor with extensive experience in quality management systems, quality assurance, software verification and validation, regulatory submissions, software life cycle, product development and IT compliance. In his past, Boris has been recognized by FDA and held position of Technical Expert for 3rd Party 510k submissions on behalf pf the FDA
Maia Pintsberg
Co-Founder
Maia Pintsberg is Certified Quality Quditor with 20+ years of Software Quality and Regulatory compliance in the medical device industry. In her carrier, Maia was responsible for developing software regulatory strategies, leading quality teams, preparation of multiple regulatory submissions (IDE, 510K and PMA), audit support (FDA, Notified Bodies, partner, supplier and internal audits). Maia has extensive experience in design controls, Quality System Regulation CFR 820; ISO13485; ISO14971; IEC62304; 21 CFR Part 11, HIPAA and more
Violetta Headley
Violetta Headley, MS is an accomplished IVD product development expert with 20+ years of experience in biotechnology and medical devices. Violetta specializes in developing and validating complex assays and diagnostic systems, with deep expertise in regulatory compliance (21 CFR Part 820, ISO 13485:2016, ISO 9001 and cGMP), risk management, and quality assurance. Violetta excels in implementing Design Control and Product Development Process (PDP) methodologies, ensuring rigorous development from concept to commercialization. Her extensive experience includes successfully navigating FDA and IVDR regulatory submissions, showcasing a comprehensive understanding of the IVD product lifecycle.