Helping medical device and diagnostic companies build, validate, and maintain FDA-compliant quality systems with confidence.

About Red Summit Consulting

With over 20 years of experience in FDA-regulated industries, Red Summit Consulting helps organizations design, implement, and maintain FDA- and ISO-compliant quality systems that stand up to scrutiny. Our team has supported everyone from early-stage startups to Fortune 500 companies in the Medical Device, In Vitro Diagnostics, and Pharmaceutical Fields.

What sets us apart is our practical, partnership-driven approach—we don’t just audit, we collaborate. From software and process validations and Part 11 compliance to mock FDA audits and CAPA planning, we help teams build reliable processes that last long after the inspection ends.

Services

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Quality Systems & Compliance

Implementation, auditing, and improvement of FDA- and ISO-compliant quality systems. We help teams prepare for FDA inspections, conduct mock audits, and maintain strong documentation and CAPA processes that stand up to regulatory review.

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Validation & Technical Support

Full support for computer system validation (CSV) and software qualification, including IQ, OQ, and PQ testing. We ensure your systems are 21 CFR Part 11 compliant—from risk assessments and SOP development to validation planning and execution.

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Clinical & Regulatory Consulting

Expert guidance for clinical trials, submissions, and global regulatory compliance. Our consultants assist with protocol development, study monitoring, and technical file creation to align your clinical data and documentation with FDA and ISO standards.