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ISO 13485:2016
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Software as Medical Device
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SOUP and OTS
Medical Apps
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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...

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Usability Validation
Usability Tests in the Time of Corona
User Interface Design
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ISO 9241
User stories
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Intended Use Description
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Verification versus Validation
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In Vitro Diagnostic Medical Device Performance Evaluation
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Telefon_weiß_1 +1 (301) 244-6335
Software (IEC 62304, FDA)
Risk Management (ISO 14971)
Clinical Evaluation
AI Medical Devices
Create QM-Systems (ISO 13485)
Mock Audits & Inspections of QM-Systems
QM-Representative
Human Factor Engineering
Regulatory Affairs
Regulatory Radar
Post Market Radar
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
Our Mission
Our Values
Certificates
The Team
Our Customers
Constance
Constance (Turmstrs.)
Frankfurt
Berlin
Peking
Silver Spring
Accommodations
Directions
Medical Device Regulation
IVD Regulation (IVDR)
Medical Device Directive
Classification
Glossary for medical device manufacturers
FDA
And more ...
Audits
CSV
Document Control
ISO 13485:2016
MDSAP
And more...
Software as Medical Device
Software Lifecycle
Safety Classes & Level of Concern
SOUP and OTS
Medical Apps
And more...
Life Cycle Risk Management
Update 14971:2012
Harm and Severity
Hazard and Hazardous Situation
Risk Acceptance
Third edition of ISO 14971
And more...
Usability Validation
Usability Tests in the Time of Corona
User Interface Design
Interest in Market Research
ISO 9241
User stories
And More...
2. Amendment to IEC 60601-1
Intended Use Description
System Architecture
Clinical Evaluation
Verification versus Validation
And more ...
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
Insurance for Clinical Investigations
Hybrid seminars hybrid conferences
In Vitro Diagnostic Medical Device Performance Evaluation
Transitional Periods
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Johner Institute North America Inc.

1738 Elton Rd., Suite 138

Silver Spring, Maryland 20903

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Johner Institut GmbH

Reichenaustr. 1

78467 Konstanz

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