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"Let me understand your business and I will guide you taking your medical products to market with a pragmatic approach"

General services

  • Is your Device, App or Software a medical device
  • What regulations are applying to your products, and consequently the work to be done
  • How do the regulations affect your development process with focus on cost and time to market
  • Definition of a pragmatic and market driven Regulatory Strategy
  • CE marking in Europe
  • FDA-clearance in USA
  • Part-time Regulatory Affairs responsible in your organisation
  • Setup or improvement of the required Quality Assurance System
  • How to approach the Personal Data Protection regulations and Cyber Security
  • Prepare for the coming Medical Device Regulation and General Data Protection Regulation. It is about time to start!

Services Healthcare Apps

  • Provide market and regulatory knowledge within Apps used in Healthcare, Mobile Health, eHealth, Telemedicine, Wearables, IoT etc.
  • Is your App a medical device or would it be wellness
  • What regulations are applying to your Apps, and consequently the work to be done
  • How do the regulations affect your development process with focus on time to market and cost?
  • How to work Agile with medical device software development
  • CE marking in Europe
  • FDA-clearance in USA
  • How to approach the Personal Data Protection regulations and Cyber Security for Apps

Contact

Niels Ole Andersen

Tel: +45 40582666

noa@noaQA.dk

 

noaQA

Skraenten 4

DK-9560 Hadsund

Denmark

 

CVR/VAT: DK38145983

 

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