CONTACT
START
ABOUT US
Who we are
Team members
Partners and associations
Company presentation
COURSES AND SEMINARS
Calendar
Customized training courses and seminars
OUR SERVICES
Medtech consulting
QA&RA manager for hire
Small Business Solutions
Medical Devices – Prestudy
Requirements analysis
Due diligence
Regulatory strategy
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
Clinical Evaluations and Clinical Studies
Clinical performance evaluations and clinical evidence reports
Technical documentation for CE marking
GSPR
Medical Devices – Manufacturing
Process validation
Computer systems validation
Medical Devices – Market access
EU
USA
Canada
Japan
China
Other countries
European Authorized Representative
Regulatory – Post-market
Internal audits
Supplier audits
FDA inspections
Notified body audits
Post market surveillance (PMS)
Regulatory surveillance
NEWS AND SHARE
News
Presentations
Publications
Templates
Videos
White papers
CAREERS
Our open positions
QAdvis presentation
Menu
Clinical Evidence
Is your product ready
to meet MDR?
Download PDF
148 x 210 mm
Scroll to top
