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Overview of my services for you
Product conception
My consulting services:
Environment and competitor analysis
Selection of applicable technologies
Product development
My consulting services:
Support of development activities
Review of development documentation
Business processes
ISO 13485:2016
ISO 9001:2015
21 CFR 820
My consulting services:
Installation and optimization of QM Systems
Audit of QM Systems
Optimization of individual business processes
Risk management
ISO 14971
My consulting services:
Conception and moderation of Risk Analysis activities
Documentation Review
Usability engineering
EN 62366
My consulting services:
Requirements Management
Documentation Review
Product approval
Europe/international
My consulting services:
Determination of regulatory path
Generation and review of technical documentation
Product Risk Classification
Conception and review of Clinical Evaluations
Market surveillance
My consulting services:
Consulting of Post-Market Surveillance activities
External representative functions
QM-Systems
IVDD/IVDR
MDD/MDR
My consulting services:
Quality Management Representative
Safety Officer according to §30 MPG
Person responsible for Regulatory Compliance according to
Art. 15 IVDR/MDR
medlaQ - Consulting for medical devices
Dr. Bernhard Gerstenecker
GENERAL INFORMATION
ADDRESS
medlaQ
Dr. Bernhard Gerstenecker
Scheffelstraße 9
78315 Radolfzell
Tel.: +49 172 3792283