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.
ISO 13485 Compliance
ISO 9001 Tailoring
FDA Compliance (21CFR820 and 21CFR210,211)
EU MDR and IVDR Expertise
Canadian CMDR Compliance
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