Are you looking for a QA & RA partner in Medical Devices? Then you are at the right place.
We deliver solutions customized to your business needs.
Making complex legislation pragmatic and user-friendly is our passion.

Welcome to QA MED Solutions

WHAT WE OFFER:

🏆 Quality Assurance: 
ISO 13485 QMS for medical devices – or your own standard
QMS implementation, Due diligence audit, Internal audit

⚙️ Regulatory and Quality training and education – customized for your needs:
EU MDR Compliance, EN ISO 13485:2016 QMS, Technical Documentation, Post Market Surveillance, Risk management, Quality Strategy Advice

🎯 MDR readiness and implementation:
Gap analysis, Clinical /regulatory strategy, preparation of Clinical evaluation and Technical documentation (primarily class I devices)

🌸 Regulatory consulting:
Gap analysis, EUDAMED registration, Risk management ISO 14971, PRRC (Person Responsible for Regulatory Compliance), Regulatory affairs training, Regulatory Strategy Advice, CE-marking, labelling and IFU advice, Recall procedures

QA MED Solutions

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