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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

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Human Factor Engineering
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Regulatory Radar
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Seminars

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
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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

Johner & Institute

Insurance for Clinical Investigations
Hybrid seminars hybrid conferences
In Vitro Diagnostic Medical Device Performance Evaluation
Transitional Periods
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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
Insurance for Clinical Investigations
Hybrid seminars hybrid conferences
In Vitro Diagnostic Medical Device Performance Evaluation
Transitional Periods
CONTINUE TO MEDICAL DEVICE UNIVERSITY
Johner-Institut arrowRegulatory AffairsarrowAnd more ...

Overview

Conformity Assessment
Medical device manufacturers have to prove compliance of the devices by following one of the conformity assessment procedures that are described in the Medical Device Directive / Regulation. Which procedure can be used for which device ...
Harmonized Standards
 
Technical Documentation
A regulatory compliant technical Documentation (Technical File) is the precondition for any medical device approval. Best practices to pass audits ~
MEDDEV 2.7/1
Revision 4 of the MEDDEV 2.7/1 guideline for clinical evaluations has been in force since 1 July 2016. It offers more detailed assistance than the previous version, but also formulates stricter requirements and surprises with a narrow focus on Europe.
CE Marking
With the CE mark manufacturers of medical devices declare conformity with the respective European directives. Even everybody calls it like this, but there is no CE certification!
Device group
generic device group, device category, device group versus device category, MDR, IVDR, device range,
Data Security and Protection Requirements for Digital Health Applications
The data security and data protection requirements for DIGA (digital health applications) go far beyond the set of questions contained in the DiGAV.
Privacy Shield Agreement
Privacy Shield Agreement: What Its End Means, GDPR, Switching to Amazon's data center site in Frankfurt?, Hosting in Amazon, Google & Co. clouds?
Post-Market Surveillance Plan: Complying with the Requirements of ISO TR 20416
Post-Market Surveillance Plan, Complying with the Requirements of ISO TR 20416
ClinicalTrials Search Mask
Why the ClinicalTrials Search Mask Could Cost You Hundreds of Thousands of Euros
CFDA, NMPA
 
Marketing Personal Protective Equipment (PPE)
Someone who wants to place personal protective equipment (PPE) on the market has to comply with different legislation to someone who wants to place medical devices (MD) on the market.
Regulatory Requirements for Medical Devices with Machine Learning
Manufacturers of medical devices with machine learning are faced with the difficult task of having to demonstrate the conformity of their devices.
The Medical Device File: What You Don’t Have to Include in This File
The Medical Device File, What You Don’t Have to Include in This File, MDR, IVDR, 21 CFR, ISO13485, FDA file, comparison of files
MDR Usability Requirements
MDR, usability, requirements, usability requirement, medical device regulation, mdd, mdd usability requirements, manufacturers
Measuring Function
The ISO 13485:2016 replaces the ISO 13485:2012. Find out more about the differences between ISO 13485:2016 and previous versions. [ROADMAP]
Distributor Requirements
Distributor, Requirements, legal security , manufacturers, mdr, medical device regulation, importer, role
Class 1 Medical Devices
 
21 CFR Part 11
 
NAKI - The German National Working Group
The National Working Group (NAKI) was created to answer questions on the implementation of the EU regulations, the MDR and the IVDR.
Accessories for Medical Devices
Medical devices accessories have to meet the same regulatory requirements as the medical device. However, there are differences, manufacturers should be aware of.
Declaration of Conformity
 
Design input
 
Design Change
A design change may require a re-approval respectively re-submission. There are many regulatory requirements related to design changes.
Essential Requirements
Medical devices have to fulfill the "essential requirements" laid down in the medical device directive respectively the "general safety and performance requirements" laid down in the medical device regulations. Get an fast overview here!
GDPR
 
EUDAMED
EUDAMED, European Database on Medical Devices, is introduced by the Medical Device Regulation MDR. In stores data about medical devices, clinical evaluations etc.
Free Sales Certificates
Many countries insist on Free Sales Certicates (FSCs) to clear medical devices. wWat FSCs are, how to obtain certificates, by whom, and at which costs
Harmonized Standards
 
IVD Software
IVD Software is standalone Software that is classified as IVD. Learn how to classify and develop the software compliant with IVDR and other regulations.
MDR Rule 11 (Software)
MDR's classification rule 11 is a nightmare: It will be a major issue for manufacturers of medical device software. Read what's new and why the EU commission needs to act.
MEDDEV Documents
 
Notified Bodies
Medical device manufacturers have to involve for approval processes notified bodies. These are companies that evaluate and certify quality management systems on behalf of national authorities.
Periodic Safety Update Report PSUR
The MDR and IVDR require a Periodic Safety Update Report (PSUR) or a Post-Market-Surveillance Report. Tips for implementation!
Post-Market Surveillance
Regulatory Requirements and Tips for Procedural Instructions considering Post-Market Surveillance, Market Surveillance and Vigilance.
Premarket Approval (510k)
 
Systems & Procedure Packs
MDR and MDD have different(!) requirements with respect to system and procedure packs. When a conformity assessment procedure is required...
Technical File versus DHF
The FDA requires in 21 CFR part 820.30 a design history file (DHF). These is part of the technical documentation, sometimes also referred to as device master record DMR.
Unique Device Identification
The MDR requires a Unique Device Identification for medical devices. It consists of a device identifier (UDI-DI) and a production identifier (UDI-DI).
Physiological processes
It is important to understand what is a vital physiological processes since the classification rules of MDD and MDR depend on this definition.
Medizinprodukte-Durchführungsgesetz (MDG)
Article about german Regulation
3D Printing in Medicine: Avoiding Regulatory Traps
3D Printing, Medicine, Regulatory Traps, Medical Devices
Qualified Person
PRRC, Qualified Person, Person Responsible for Regulatory Compliance, Regulatory Compliance, MDR, IVDR
Request versus Application for Certification
 
Coronavirus
Coronavirus, China, in vitro diagnostic medical devices, WHO ,Epidemic, pandemic, coronavirus diagnostic , device development
Registration of Medical Devices in Brazil
 
Regulatory Update
Regulatory Update or How to Stay Up to Date with Regulatory Requirements,certainty during audits National laws, MPG MPDG
Authorization of Medical Devices in Japan
The authorization of medical devices in Japan represents a big challenge for European manufacturers. But it’s not one they should shy away from, because Japan is one of the 10 biggest markets in the world.
Medizinprodukte-Anwendermelde- und Informationsverordnung – MPAMIV
The Medizinprodukte-Anwendermelde- und Informationsverordnung (MPAMIV) replaces the Medizinprodukte-Sicherheitsplanverordnung (MPSV).
Saudi Arabia: Is It Worth Having Your Medical Devices Authorized?
Saudi Arabia, Is It Worth Having Your Medical Devices Authorized?, big market, investments in the healthcare market, Authorization of medical devices
State of the Art: It’s Worse Than You Think
State of the Art: It’s Worse Than You Think, difficult to define, No harmonized standards, Incorrect and inconsistent translations
The Clinical Evaluation Literature Search
The Clinical Evaluation Literature Search, 6 Tips to Save You Time and Stress, MEDDEV 2.7/1 Revision 4, MDCG documents, Literature search protocol
International Medical Device Authorizations: 5 Steps to New Markets
International Medical Device Authorizations, 5 Steps to New Markets, international authorizations, “International authorization” checklist
MDCG 2020-5
MDCG 2020-5: The End of the Equivalence Route for Clinical Evaluations?, Regulatory requirements for equivalence, MDR, equivalence
The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?
The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?, Laboratory developed tests (LDT), IVDR
Medical Device Consultant
Medical Device Consultant – Only A German Concept?, MPG, MPDG, roles and occupations,Regulatory requirements, Comparison of the requirements
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USA

Johner Institute North America Inc.

1738 Elton Rd., Suite 138

Silver Spring, Maryland 20903

How to find us Pfeil_weiß

Germany

Johner Institut GmbH

Reichenaustr. 1

78467 Konstanz

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