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
Safety and Performance Based Pathway
Mit DiGAs auf dem Markt bestehen
DiGAs kurz erklärt
IVDR-Konformitätsbewertungsverfahren
Transitional periods for IVD
MDR Article 61(10)
FDA-Gruppierung von Medizinprodukten verstehen
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
10/02/2025
DiGAs: Ihr Kompass durch den Regulierungsdschungel!
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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
Safety and Performance Based Pathway
Mit DiGAs auf dem Markt bestehen
DiGAs kurz erklärt
IVDR-Konformitätsbewertungsverfahren
Transitional periods for IVD
MDR Article 61(10)
FDA-Gruppierung von Medizinprodukten verstehen
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