Knightmark Quality
Expert QMS & Quality Consulting for Medical Device Manufacturers
About Knightmark Quality
Knightmark Quality LLC is a quality and regulatory consulting firm dedicated to helping medical device manufacturers navigate complex, multi-jurisdictional compliance requirements. With hands-on, manufacturing-side quality engineering experience across multi-site medical device operations, we deliver practical, audit-ready systems that go beyond theoretical frameworks. Our expertise spans FDA 21 CFR Part 820/QMSR, ISO 13485:2016, EU MDR 2017/745, MDSAP, and Health Canada CMDR regulations.
We partner with medical device companies to build, audit, and strengthen quality management systems that ensure compliance and operational excellence. Our mission is to transform regulatory complexity into competitive advantage, enabling our clients to bring safe, effective products to market with confidence while maintaining the highest standards of quality and compliance.
Our Services
QMS Gap Assessment & Buildout
Comprehensive gap assessments of your quality management system aligned with FDA 21 CFR Part 820/QMSR, ISO 13485:2016, EU MDR, MDSAP, and Health Canada CMDR. We develop targeted remediation plans and quality system procedures (SOPs/WIs) to close compliance gaps and strengthen your QMS foundation.
Mock Audits & Audit Support
Prepare for regulatory inspections with confidence through internal audit support and mock MDSAP/ISO audits conducted by experienced quality professionals. We identify vulnerabilities, provide actionable feedback, and ensure your systems are audit-ready before official inspections.
Quality Consulting Services
Design and implement robust CAPA systems, complaint-handling procedures, post-market surveillance programs, and eQMS solutions. We help you establish the operational infrastructure needed to manage product quality, regulatory reporting, and continuous improvement throughout the product lifecycle.