"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 ApS
Anton Bast Vej 5
DK-9480 Loekken
Denmark
CVR/VAT: DK39644576
© Copyright, All Rights Reserved