Quality Systems Implementation
Complete QMS development compliant with regulatory requirements
We specialize in developing and implementing Quality Management Systems
(QMS) that ensure compliance with industry standards such as ISO 13485, 21 CFR 820, and MDR.
Our services support the entire lifecycle of your medical device, from design to post-market
surveillance.
Our Quality System Services
We help you implement robust QMS frameworks that integrate with your existing processes:
- QMS Design & Development: Developing QMS from scratch, tailored to meet
the specific needs of your device.
- Document Control: Establishing effective document management and
traceability systems for compliance.
- Supplier Management: Ensuring that suppliers meet quality standards and
are properly managed.
- Risk Management: Identifying and mitigating potential risks to ensure
device safety and effectiveness.
- Audits & Compliance: Conducting internal audits to ensure ongoing
compliance with FDA, ISO, and other regulatory bodies.