Quality Management System Implementation & Maintenance

Quality Management System Implementation & Maintenance


Fiunex is dedicated to ensuring that our customers in the medical industry achieve and maintain the highest quality standards in their Quality Management Systems (QMS). Our team of skilled auditors will conduct independent evaluations of your QMS to ensure its compliance with ISO 13485 requirements.

Obtaining ISO 13485 certification through Fiunex instills confidence in the processes driving the manufacture of your medical devices, supported by our reputable status as a Notified Body.

ISO 13485 certification can not only provide a competitive edge among medical device manufacturers but also enhance trust in your manufacturing procedures.



Quality Management System Development

ISO 13485 Compliance

ISO 9001 Tailoring

FDA Compliance (21CFR820 and 21CFR210,211)

EU MDR and IVDR Expertise

Canadian CMDR Compliance

Quality Management System (QMS) Maintenance

QMS Audits and Assessments

Document Control and Management

Training and Education Programs

Corrective and Preventive Actions (CAPA)

Continual Improvement Initiatives

Regulatory Compliance Monitoring

Risk Management and Mitigation

Supplier Quality Management

Change Control Management

Internal and External Quality Audits