Quality you can trust
Delivering reliable diagnostic solutions through robust quality systems, regulatory compliance and continuous improvement.
Our Commitment to Quality
Quality is embedded in everything we do. From development to post-market activities, our processes ensure reliability, consistency and compliance with applicable regulatory requirements.
Quality Management
Robust processes ensuring consistency, traceability and compliance.
Regulatory Compliance
Compliance with applicable international regulatory requirements.
Product Reliability
Ongoing monitoring and optimization of our processes and products.
Continuous Improvement
Robust processes ensuring consistency, traceability and compliance.
Our Quality Management System
Our Quality Management System is certified to ISO 13485 and structured to ensure the effectiveness and efficiency of our processes across the organization.
Our Quality Management System (QMS) is MDSAP certified, assessing compliance with ISO 13485and regulatory requirements of:
Canada | United States | Brazil | Australia | Japan
Regulatory Compliance
Regulatory compliance is managed through a combination of certified quality processes, conformity assessment activities and support for international market registrations.
IVDR Compliance
Our products are developed and manufactured under processes aligned with the requirements of the IVDR (EU 2017/746).
CE-Marked Products
Our products are CE marked in accordance with the applicable European regulatory requirements.
Global Regulatory Support
We provide documentation, technical files and regulatory support to our distributors and partners for local registrations and market access.
Quality Throughout the Product Lifecycle
Design & Development
Planning, risk management, requirements definition and design controls to develop safe and effective products.
Verification & Validation
Rigorous verification and validation activities to ensure product performance meets intended use.
Manufacturing
Controlled and documented processes to ensure consistency and reproducibility.
Quality Control
Incoming, in-process and final product testing to ensure compliance with specifications.
Post-Market Surveillance
Monitoring product performance, handling feedback and driving continuous improvement.
Certifications & Documents
Our quality system and products are supported by internationally recognized certifications and documentation.
