QA MED Solutions

Management consulting, Ce labelling of class i medical devices, Medical device regulation, Iso 13485, Medical gloves
Founded in 2016
Middelfart, Region Syddanmark
None

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