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+1 (301) 244-6335
Consulting & Approval
Technical Documentation
Software (IEC 62304, FDA)
Risk Management (ISO 14971)
Clinical Evaluation
AI Medical Devices
QM-Systems
Create QM-Systems (ISO 13485)
Mock Audits & Inspections of QM-Systems
QM-Representative
Services
Human Factor Engineering
Regulatory Affairs
Regulatory Radar
Post Market Radar
Training Seminars
Seminars
Usability, Requirements & IEC 62366
CPMS Seminar
Seminar Medical Software
Medical Device Regulation
Person Responsible for Regulatory Compliance
Internal Auditor Seminar
Human Factors Engineering
Seminar Risk Management & ISO 14971
Inhouse Seminars
Medical Device Regulatory Affairs
About us
The Company
Our Mission
Our Values
Certificates
People
The Team
Our Customers
Locations
Constance
Constance (Turmstrs.)
Frankfurt
Berlin
Peking
Silver Spring
Accommodations
Directions
Articles
Regulatory Affairs
Medical Device Regulation
IVD Regulation (IVDR)
Medical Device Directive
Classification
Glossary for medical device manufacturers
FDA
And more ...
QM System & ISO 13485
Audits
CSV
Document Control
ISO 13485:2016
MDSAP
And more...
Software & IEC 62304
Software as Medical Device
Software Lifecycle
Safety Classes & Level of Concern
SOUP and OTS
Medical Apps
And more...
Risk Management & ISO 14971
Life Cycle Risk Management
Update 14971:2012
Harm and Severity
Hazard and Hazardous Situation
Risk Acceptance
Third edition of ISO 14971
And more...
Usability / Human Factors Engineering
Usability Validation
Usability Tests in the Time of Corona
User Interface Design
Interest in Market Research
ISO 9241
User stories
And More...
Product Development
2. Amendment to IEC 60601-1
Intended Use Description
System Architecture
Clinical Evaluation
Verification versus Validation
And more ...
Health Care
Health Care Facilities
Regulatory Science
Digital Health Applications Ordinance
Medical Devices as Disability Aids
Planning Sample Sizes for Clinical Studies of Medical Devices and IVDs
Johner & Institute
Insurance for Clinical Investigations
Hybrid seminars hybrid conferences
In Vitro Diagnostic Medical Device Performance Evaluation
Transitional Periods
Essential Performance in Medical Devices
Our Latest Articles
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