QA MED Solutions
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 SolutionsWHAT WE OFFER:🏆 Quality Assurance: ISO 13485 QMS for medical devices – or your own standardQMS 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
Company Metrics
- Employees: 1-10
- Monthly Visits: None
- Tech Stack: None active products
Financial Information
- Estimated Revenue: Not available
- Total Funding: None None
- Last Funding: None None (None)
- Funding Status: None
Technology Stack
QA MED Solutions actively uses None products in their tech stack.
Market Presence
Industries: Management consulting, Ce labelling of class i medical devices, Medical device regulation, Iso 13485, Medical gloves
Headquarters: Middelfart, Region Syddanmark