Legal, regulatory & quality compliance disclaimer

Scope and limitations of services

Katzen Consulting provides program and project management consulting services. Any discussion, planning support, template, or deliverable related to regulatory affairs, quality management, regulatory submissions (including 510(k), PMA, CE marking, or EU IVDR/MDR technical documentation), audits, inspections, design controls, verification and validation, or other regulated activities is intended solely to support the Client’s project planning, coordination, scheduling, and execution oversight.

Katzen Consulting does not provide legal, regulatory, or quality-assurance advice, and nothing in any engagement, proposal, deliverable, training material, or communication constitutes a regulatory, quality, or legal opinion, or a guarantee of any outcome. All regulatory and quality-related decisions, interpretations, compliance determinations, technical assessments, risk acceptance, and formal approvals remain the sole responsibility of the Client’s qualified and duly authorized Regulatory Affairs, Quality Assurance, Quality Control, Legal, and other designated personnel.

Client responsibilities

Such personnel must independently review, verify, approve, and, where applicable, sign all deliverables, submissions, and documentation in accordance with the Client’s own procedures and all applicable laws, regulations, and standards, domestic and international, including but not limited to FDA regulations, ISO standards, the EU IVDR/MDR, and other jurisdiction-specific requirements.

No substitute for internal functions

Engagement with Katzen Consulting does not replace, substitute for, or diminish the Client’s obligation to maintain its own qualified regulatory, quality, legal, and technical functions. Katzen Consulting makes no representation, warranty, or guarantee, express or implied, regarding regulatory acceptance, audit or inspection outcomes, product clearance or approval, or any other regulatory or quality result, and assumes no liability for the Client’s regulatory or quality decisions or outcomes. This disclaimer applies to all content on this website and to all consulting and training services described herein, regardless of format or delivery method.