Services
Medical Devices
Preclinical research
Usability
Design verification and product validation
Clinical studies
Project management
Monitoring
Data management / Biostatistics
Clinical study vs. clinical trial
Clinical evaluation
Literature review
Clinical evaluation plan
Conducting the clinical evaluation
Summary of Safety and Clinical Performance
Quantitative clinical evaluation
Regulatory Affairs
Biological evaluation
Risk management and instructions for use
International Regulatory Affairs
Post-market surveillance
PMS plans and reports
Post-market clinical follow-up
OntoPMS
In vitro Diagnostics
Performance evaluation
Clinical evidence
Literature review
Regulatory Affairs
Expert information and seminars
Workshops and seminars
Verlängerung der Übergangsfristen in der MDR
PSUR - MDCG 2022-21
White Papers
FDA-Gruppierung von Medizinprodukten verstehen
IVDR Übergangsfristen und Anforderungen
PSUR according to MDCG 2022-21
Clinical Evaluation Consultation Procedure
Borderline products
Post market surveillance
Risk management and warnings
Instructions for use - more than just a duty
Well-established technologies
Peer-reviewed publications
Company
Our team
Medical consiliary service
News
Contact
Deutsch
Open/Close
11/15/2022
Klinische Bewertung - Lessons learned
WissensRaumWebinar in Kooperation mit Spectaris
Back
Services
Medical Devices
Preclinical research
Usability
Design verification and product validation
Clinical studies
Project management
Monitoring
Data management / Biostatistics
Clinical study vs. clinical trial
Clinical evaluation
Literature review
Clinical evaluation plan
Conducting the clinical evaluation
Summary of Safety and Clinical Performance
Quantitative clinical evaluation
Regulatory Affairs
Biological evaluation
Risk management and instructions for use
International Regulatory Affairs
Post-market surveillance
PMS plans and reports
Post-market clinical follow-up
OntoPMS
In vitro Diagnostics
Performance evaluation
Clinical evidence
Literature review
Regulatory Affairs
Expert information and seminars
Workshops and seminars
Verlängerung der Übergangsfristen in der MDR
PSUR - MDCG 2022-21
White Papers
FDA-Gruppierung von Medizinprodukten verstehen
IVDR Übergangsfristen und Anforderungen
PSUR according to MDCG 2022-21
Clinical Evaluation Consultation Procedure
Borderline products
Post market surveillance
Risk management and warnings
Instructions for use - more than just a duty
Well-established technologies
Peer-reviewed publications
Company
Our team
Medical consiliary service
News
Contact
Deutsch
Open/Close