Quality Management Systems
At Medalps, we help medical device manufacturers establish and maintain compliant, efficient, and pragmatic Quality Management Systems.
Our services - tailored to your needs
Whether you are preparing for your first ISO 13485 certification, transitioning to EU MDR, or expanding to new markets, our QMS services are tailored to your needs. We offer flexible, hands-on support — from strategic planning to operational implementation.
We adapt to your structure, whether you're a start-up, an established manufacturer, distributor, importer, or service provider.
Our lean and scalable approach ensures your system is not just compliant, but truly useful in daily operations.
What we can do for you
Our services include:
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Gap analysis and QMS strategy definition
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Development or update of your Quality Manual and procedures
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Implementation of ISO 13485 and MDR-compliant processes
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Internal audits and audit readiness support
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Audit findings remediation
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Post-market surveillance process implementation (complaints, vigilance, FSCA)
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Acting as external Quality Manager for small organizations