Quality Services
Quality Services are designed to help you implement, update, and expand your Quality Management System (QMS) in compliance with QMSR, ISO 13485, and other relevant standards. Whether you’re adapting to new regulations or expanding your scope, we provide the expertise needed to ensure a clean and effective quality system.
Standard QMS (QMSR / 13485)
Implement or enhance your Quality Management System in compliance with QMSR and ISO 13485 standards, ensuring robust processes and regulatory alignment.
QMS Tailored to New LDT Regulations (QMSR)
Develop a Quality Management System specifically tailored to the new Laboratory Developed Test (LDT) regulations, ensuring compliance and operational efficiency.
QMS Update from 21 CFR to QMSR
Transition your existing Quality Management System from 21 CFR Part 820 to the new QMSR framework, maintaining compliance and optimizing your quality processes.
QMS Scope Expansion
Expand your QMS to meet new regulatory requirements, whether adding EUDAMED or transitioning from specification developer to manufacturer under FDA regulations.
Sol MedTech 