Regulatory Pathways & MDR
QMS (MDR – ISO13485)
Management responsability
Resources management
Product realization
Measurement, analysis and improvement
Certification
Tactical implementation
Design & Development ISO13485 and Risk Mgmt ISO14971
Clinical Evidence & Clinical Evaluation
Post-Market Surveillance & materiovigilance
GDPR cybersecurity
Software as a MD & MD embedded software
Notified Bodies / AFMPS
Certification in other countries (US, Asia, Japan)