Medical Device Quality System Solutions
Irvine, United States (US) · Health and Medical
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Last verified
May 2026
Overview
Medical Device Quality System Solutions is a US-based consulting firm specializing in quality systems and compliance solutions for the medical device industry.
We support medical device companies navigating the complexities of regulatory requirements, including FDA 21 CFR 820, ISO 13485, ISO 9001, MDD, MD SAP, and the EU MDR. Our team provides expert guidance on quality system restructuring, change control, CAPA, complaint management, and audit readiness.
MDQSS offers tailored solutions to address specific challenges, from gap assessments and documentation updates to internal audits and technical file preparation for Notified Bodies. We are committed to helping our clients achieve and maintain compliance, ensuring the safety and efficacy of their medical devices.
We support medical device companies navigating the complexities of regulatory requirements, including FDA 21 CFR 820, ISO 13485, ISO 9001, MDD, MD SAP, and the EU MDR. Our team provides expert guidance on quality system restructuring, change control, CAPA, complaint management, and audit readiness.
MDQSS offers tailored solutions to address specific challenges, from gap assessments and documentation updates to internal audits and technical file preparation for Notified Bodies. We are committed to helping our clients achieve and maintain compliance, ensuring the safety and efficacy of their medical devices.
Contact Details
info@mdqss.com
Irvine, United States (US)
Founded
2019
Company Type
Sole Proprietorship
Employees
2-10
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