QA MED Solutions
@qa_med_solutions
Middelfart, South Denmarkhttp://www.qamedsolutions.com Business Consulting and ServicesOverview
About 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
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