Careers/Open positions | QAdvis Shop
  • 0Shopping Cart
QAdvis AB
  • ABOUT US
    • Who we are
    • Framtidens arbetsplats
      (in swedish)
    • Partners and collaborations
    • Company presentation (pdf)
  • OUR SERVICES
    • Medtech consulting
      • PRRC
      • QA&RA manager for hire
      • Small Business Solutions
      • MDR transfer process
      • IVDR transfer process
      • Due diligence
    • Medical Devices – Prestudy
      • Requirements analysis
      • Regulatory strategy
    • Medical Devices – Clinical evidence
      • Clinical Evidence
      • Clinical evaluation / Clinical investigation
      • Performance evaluation (IVD)
    • Medical Devices – Development
      • Risk management
      • Software risk management
      • Software validation
      • Software Quality Assurance
      • Quality management systems
      • Unique device identification
      • Product verification and validation
      • Computer systems validation
      • Technical documentation for CE marking
        • GSPR
    • Medical Devices – Manufacturing
      • Process validation
      • Computer systems validation
    • Medical Devices – Market access
      • EU
      • European Authorized Representative
      • UK Responsible Person
      • USA
      • Canada
      • Japan
      • China
      • Other countries
    • Regulatory – Post-market
      • Internal audits
      • Supplier audits
      • FDA inspections
      • Notified body audits
      • Post market surveillance (PMS)
      • Regulatory surveillance
  • COURSES AND SEMINARS
    • Courses and seminars
    • Previous presentations, seminars and webinars
  • NEWS AND SHARE
    • News
    • Newsletter
      QAdvis News
    • Publications
    • White papers
  • CONTACT
  • Search
  • Menu Menu

Shop

Books and templates for your needs

View cart “MDR Declaration of Conformity” has been added to your cart.
  • Sort by Default
    • Default
    • Custom
    • Name
    • Price
    • Date
    • Popularity (sales)
    • Average rating
    • Relevance
    • Random
    • Product ID
  • Display 6 Products per page
    • 6 Products per page
    • 12 Products per page
    • 18 Products per page

  • MDR General Safety and Performance Requirements Checklist

    € 130.00 "excl VAT"
    Add to cart Show Details

  • MDR Technical Documentation

    € 150.00 "excl VAT"
    Add to cart Show Details

  • MDR Declaration of Conformity

    € 40.00 "excl VAT"
    Add to cart Show Details

  • MDR Templates – All three documents

    € 320.00 "excl VAT"
    Add to cart Show Details

  • MDR Book
    Regulation (EU) 2017/745 of the European Parliament and of the Council

    € 25.00 "excl VAT"
    Add to cart Show Details

  • IVDR Book
    Regulation (EU) 2017/746 of the European Parliament and of the Council

    € 25.00 "excl VAT"
    Add to cart Show Details

We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.

Contact Us

Lund office +46 46 286 88 90
Stockholm office +46 8 621 01 05
Sales and QAdvis UK +46 8 621 01 05
QAdvis EAR +46 8 621 01 05

Email  |  LinkedIn

Scroll to top