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QMS Development
Establish a robust Quality Management System from the ground up
Developing a Quality Management System (QMS) is a foundational step for any medical device company. A well-designed QMS ensures your processes are compliant from day one, setting the stage for long-term success, product quality, and patient safety.
We help you build a QMS that meets regulatory requirements while being practical and efficient for your business operations.
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We can guide you through every phase of QMS development, from initial planning to full implementation. Our end-to-end support ensures that all aspects of your system are properly structured to support your unique business needs and growth trajectory.
QMS Development Services
1
Full QMS Implementation
For new companies or those without a QMS, we partner with you to build a complete system from scratch that is compliant with ISO 13485 and other relevant regulations
2
Modular QMS Development
If you have some QMS elements in place, we can help you develop specific modules or procedures to fill the gaps and create a comprehensive system.
3
Documentation & Procedure Creation
​We help you author and refine all essential QMS documentation, including quality manuals, standard operating procedures (SOPs), and work instructions.
Your Development Deliverables
What to expect after a development project
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For every project, you will receive a detailed implementation report that outlines the work completed, the new processes established, and a clear roadmap for your QMS management.
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Compliance Checklist: A detailed checklist to confirm your QMS's adherence to relevant regulatory standards.
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Onboarding: A hands-on onboarding process with relevant functions in your organisation to ensure efficient operation of your new system.