medlaQ | Consulting for medical devices

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

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

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

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