Professional Disclaimer

Effective Date: January 1, 2026

1. General Information Only

The information provided on the Young Partners LLC website is for general informational and educational purposes only. It is not intended to be, and should not be construed as, professional consulting advice, legal advice, or regulatory guidance.

2. No Professional Relationship

Accessing this website, reading its content, or contacting us does not establish a consultant-client relationship. A formal consulting engagement requires:

  • A written consulting agreement
  • Assessment of your specific circumstances and needs
  • Agreed-upon scope of services and deliverables
  • Formal engagement terms and conditions

3. Not a Substitute for Professional Consultation

Website content should not be used as a substitute for professional consultation regarding:

  • FDA regulatory strategy and compliance
  • ISO certification and quality management systems
  • Medical device design controls and risk management
  • Regulatory submissions (510(k), PMA, IDE, etc.)
  • Quality system audits and remediation
  • Supplier qualification and management
  • Clinical trials and validation studies
  • Any specific quality or regulatory matters

4. Industry-Specific Disclaimer

4.1 Medical Device Regulations

Medical device regulations are complex and constantly evolving. FDA requirements, ISO standards, and international regulations change frequently. Information on this website may not reflect the most current requirements. Always:

  • Verify current regulations with appropriate authorities (FDA, Notified Bodies, etc.)
  • Consult with qualified regulatory professionals for specific guidance
  • Review the latest published guidance documents and standards
  • Consider your device-specific requirements and risk classification

4.2 Quality Systems and Compliance

Quality system requirements vary based on:

  • Device classification (Class I, II, III)
  • Intended use and indications for use
  • Target markets (U.S., EU, other international)
  • Manufacturing processes and technologies
  • Company size and organizational structure

Generic information on this website cannot address your specific situation without proper assessment.

5. No Guarantees of Outcomes

Young Partners LLC makes no guarantees, warranties, or representations regarding:

  • FDA approval or clearance of your device
  • ISO certification or CE Mark approval
  • Successful audit outcomes
  • Resolution of regulatory issues or warning letters
  • Timeline for regulatory submissions or approvals
  • Market success or commercialization outcomes
  • Achievement of specific business objectives

Regulatory outcomes depend on many factors including device design, clinical data, manufacturing capabilities, and regulatory authority decisions.

6. Accuracy and Completeness

While we strive to provide accurate information, we make no representations or warranties regarding:

  • Accuracy, completeness, or reliability of website content
  • Applicability to your specific situation
  • Currency of regulatory information or standards
  • Interpretation of regulations or guidance documents

7. Case Studies and Examples

Any case studies, examples, or success stories mentioned on this website:

  • Are provided for illustrative purposes only
  • May be simplified or anonymized
  • Do not guarantee similar results for your situation
  • Reflect specific circumstances that may not apply to you
  • Are not comprehensive descriptions of all factors involved

8. Third-Party Information

This website may reference or link to third-party resources, including:

  • FDA guidance documents and regulations
  • ISO and IEC standards
  • Industry publications and articles
  • Other professional organizations

We are not responsible for the accuracy, completeness, or reliability of third-party content. Always verify information with original sources.

9. Confidentiality Notice

Do not submit confidential, proprietary, or trade secret information through this website unless:

  • We have a signed non-disclosure agreement in place
  • A formal consulting engagement has been established
  • You have received explicit authorization to share such information

Unsolicited confidential information submitted without a formal agreement may not be protected.

10. Regulatory Authority Decisions

Young Partners LLC does not:

  • Make regulatory decisions on behalf of FDA, Notified Bodies, or other authorities
  • Have authority to approve, clear, or certify medical devices
  • Guarantee any specific regulatory outcomes
  • Control regulatory authority review processes or timelines

All regulatory decisions are made solely by the appropriate regulatory authorities.

11. Changes in Regulations

The medical device regulatory landscape changes continuously. Recent and upcoming changes may include:

  • New FDA guidance documents
  • Updated ISO/IEC standards
  • EU MDR/IVDR requirements
  • Cybersecurity and AI/ML regulations
  • Post-market surveillance requirements

Always consult current regulations and seek professional guidance for compliance.

12. Independent Verification

You should independently verify all information and:

  • Consult with your own legal counsel
  • Engage qualified regulatory consultants
  • Review primary source documents (regulations, standards, guidance)
  • Conduct your own research and due diligence
  • Assess information in context of your specific device and situation

13. Limitation of Liability

Young Partners LLC shall not be liable for any decisions made or actions taken based on information obtained from this website. Users assume all risks associated with using website content.

14. Professional Standards

Our consulting services, when formally engaged, adhere to:

  • Professional ethical standards
  • Industry best practices
  • Applicable quality standards and regulations
  • Confidentiality and non-disclosure obligations

15. Updates to This Disclaimer

We may update this disclaimer periodically. Material changes will be posted on this page with an updated effective date.

16. Questions and Consultation

If you have specific questions about quality systems, regulatory compliance, or our consulting services, please contact us for a formal consultation:

Young Partners LLC
Email: contact@youngpartners.llc
Phone: 408.421.4377
Location: SF Bay Area, California

17. Acknowledgment

By using this website, you acknowledge that you have read, understood, and agree to this disclaimer. If you do not agree, please do not use this website or rely on its content.