QSOne
QSOne Inc. is a global medical device consulting company dedicated to providing FDA regulatory support, manufacturing assistance, and market access services for medical device companies worldwide. Established in 2001, QSOne helps clients navigate regulatory processes in the US, EU, and Asia, offering services including registration, compliance, quality systems, and distribution support. With offices in Arizona, France, and Malaysia, QSOne aims to facilitate global market entry and ensure regulatory compliance for medical devices.
Industries
Nr. of Employees
small (1-50)
Services
Consulting and support for device registration processes required to manufacture or distribute medical devices in the United States and European Union.
Support for U.S. FDA requirements including establishment registration, device listing, 510(k) submissions, PMA, IDE, QSR compliance, labeling, and MDR processes.
Guidance on EU directives, harmonized standards, selection of conformity assessment modules, Technical File preparation, and coordination with notified bodies; assistance with Certificates of Free Sale and EU representation.
Assistance to develop, align, and certify quality management systems including ISO standards and QSR alignment, CAPA implementation, and audit preparation.
Training programs including Six Sigma belt certification levels and quality systems/audit training such as QSIT, internal and external audit courses, and CAPA training.
Support for prototyping, contract manufacturing coordination, and implementation of gated product development processes from define through implementation phases.
Consulting and support for device registration processes required to manufacture or distribute medical devices in the United States and European Union.
Support for U.S. FDA requirements including establishment registration, device listing, 510(k) submissions, PMA, IDE, QSR compliance, labeling, and MDR processes.
Guidance on EU directives, harmonized standards, selection of conformity assessment modules, Technical File preparation, and coordination with notified bodies; assistance with Certificates of Free Sale and EU representation.
Assistance to develop, align, and certify quality management systems including ISO standards and QSR alignment, CAPA implementation, and audit preparation.
Training programs including Six Sigma belt certification levels and quality systems/audit training such as QSIT, internal and external audit courses, and CAPA training.
Support for prototyping, contract manufacturing coordination, and implementation of gated product development processes from define through implementation phases.
Expertise Areas
- Regulatory compliance for medical devices (FDA and EU)
- CE marking and EU conformity assessment
- Quality management systems and ISO certification
- Medical device registration and global market access
Key Technologies
- Quality Management Systems (QMS)
- Regulatory submission processes (510(k), PMA, IDE)
- CE conformity assessment and Technical File preparation
- GxP/GMP/GCP/GLP standards
News & Updates
Industry-specific content that provides useful takeaways and demonstrates expertise.
Industry-specific content that provides useful takeaways and demonstrates expertise.