Newsletter, information on our seminars and courses – SIGN UP HERE!
ABOUT US
Who we are
Gasell Company 2021
Framtidens arbetsplats
(in swedish)
Partners and collaborations
Certification (pdf)
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)
Summary of Safety and Clinical Performance (SSCP)
Summary of Safety and Performance (SSP)
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
EAR – European Authorized Representative
UKRP – 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 / SHARE
News
Newsletter
QAdvis News
Publications
White papers
CONTACT
CAREER
Search
Menu
Menu
Japan
Define requirements and assess compliance
Handle registration and amendment
Contact me for further information
Nils-Åke Lindberg
Office +46 8 621 01 05 or
send me an e-mail
Scroll to top