Qa Med Solutions

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