Regulation & registration in the medical device field
Regulatory & registration consulting services in the medical device field
Global regulatory strategy medical device
Medical devices classification based on target markets regulation
Technical file preparation
Registration of medical devices in the FDA 510K and PMA
CE mark Eu. registration for medical device
CE mark registration based on MDD and MDR
Quality management system establishment
Validation and Verification (V&V)
Quality, regulation and validation training
Risk assessment and risk analysis
Design review and design control
Medical device clinical trials
Bio-compatible materials
ISO 13485 certification
ISO 14001, ISO 27001, ISO 27799 and ISO 17025 certification
Medical device package label design and texts based on target market regulation
Medical device registration in the Israeli ministry of health
Pre-inspection audit and gap analysis towards FDA/NB audit
HIPAA, SCO2 and GDPR
Other medical device services
