Welcome to the seminars at the Johner Institute

With the seminars at the Johner Institute, you get first-hand knowledge. Knowledge proven in practice that you can implement directly in your company. Knowledge that will make your daily work easier. Knowledge that you will use to argue with experts on an equal footing.

SEMINAR DATES

Date Title Speaker Location Language Price
(plus VAT)
Seats available Registration
-

Europe/Berlin
Christian Rosenzweig
English
1600 €
Seats available
https://johner-institute.com/index.php?id=0
Risk Management and ISO 14971 (English)
Johner Institute

Europe/Berlin
Bernhard Gerstenecker
English
390 €
Seats available
https://johner-institute.com/index.php?id=0
Medical Device Consultant MPDG (Englisch)
Johner Institute
-

Europe/Berlin
Mario Klessascheck
English
1600 €
Seats available
https://johner-institute.com/index.php?id=0
IEC 60601-1 Medical Electrical Equipment Safety Seminar (English)
Johner Institute
-

Europe/Berlin
Certified ISO 13485 Lead Auditor Course (five days)
Andreas Kalchschmid-Lehmann, Claudia Volk
English
3600 €
Seats available
https://johner-institute.com/index.php?id=0
Certified ISO 13485 Lead Auditor Course (five days)
Johner Institute
-

Europe/Berlin
Urs Müller, Daniel Reinsch
English
3320 €
Seats available
https://johner-institute.com/index.php?id=0
CPMS - Certified Professional for Medical Software (English)
Johner Institute
-

Europe/Berlin
Internal Auditor (English)
Andreas Kalchschmid-Lehmann, Claudia Volk
English
1360 €
Seats available
https://johner-institute.com/index.php?id=0
Internal Auditor (English)
Johner Institute
-

Europe/Berlin
Christian Rosenzweig
English
1360 €
Seats available
https://johner-institute.com/index.php?id=0
IT security for medical devices and IEC 81001-5-1 (English)
Johner Institute
Seats available
Seats available
Only a few seats left
Only a few seats left
Booked out
Booked out

 

Seminar Overview

 

Computerized System Validation - CSV

In the Computerized Systems Validation (CSV) seminar, you will learn how to validate your computer software quickly and in compliance with the requirements of ISO 13485:2016 and 21 CFR part 820.

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CPMS

This training is the ideal preparation for the examination „Certified Professional for Medical Software“.

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Risk Management and ISO 14971

We are happy to discuss your specific files and subject them to a "quick check" upon request.

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IT Security of Medical Devices

In this seminar, manufacturers and operators of medical devices learn about and implement the regulatory requirements for IT security and data protection. This seminar also addresses the EU General Data Protection Regulation (GDPR).

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PRRC

MDR 2017/745 and IVDR 2017/746 require in Article 15 that all manufacturers appoint a "person responsible for regulatory compliance" from 26.05.2021 (MDR) resp. from 26.05.2022 (IVDR). In this seminar we address the requirements in detail and present best practices for implementation. We cover liability, internal/ external PRRC, joint responsibility, how to handle conflicts and required expertise.

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Basic seminar ISO 13485

During this seminar you will learn to understand the ISO 13485 standard, to implement its requirements and to create the conditions for successful audits and certifications.

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Compact seminar Medical Software & IEC 62304

This seminar provides a compact introduction to the topic of development, quality assurance and approval of medical software.

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IEC 60601-1

The IEC 60601 family of standards specifies requirements for medical electrical equipment. IEC 60601-1 is the most important standard in this family and defines the requirements for basic safety and essential performance characteristics of medical devices.

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Our Trainings

CPMS

The seminar "Certified Professional for Medical Software" (CPMS) prepares you perfectly for the exam or certification. It deals with all issues such as legal bases, QM-system, IEC 62304 and software development, usability (usability file), medical computer science, risk management and ISO 14971.

Risk Management & ISO 14971

Starting with the basics of risk management and ending with advanced topics such as quantitative derivation of risk acceptance: This seminar teaches you all you need to know to perform medical device risk management not only compliant to ISO 14971 but also to prioritize not only your V&V activities. 

Inhouse Seminars

Customised training for you and your employees exclusively. We adapt the seminars to your specific needs and to the level of Knowledge of your team. We guarantee absolute confidentiality and a tailor-made seminar for you.

Internal Auditor

This two day training will enable the participants to plan and perform internal audits, write value adding and compliant audit reports and follow up audit findings effectively. On the first day we learn all about requirements and best practices of internal audits, and on day two the participants put theory into practice and perform a real internal audit by auditing the instructor. We do three internal audits with feedback sessions, so everybody gets a turn. Focus of this training is on auditing techniques not on the requirements, so this training enables you to audit against any regulations.

PRRC

MDR 2017/745 and IVDR 2017/746 require in Article 15 that all manufacturers appoint a "person responsible for regulatory compliance" from 26.05.2020 (MDR) resp. from 26.05.2022 (IVDR). In this seminar we address the requirements in detail and present best practices for implementation. We cover liability, internal/ external PRRC, joint responsibility, how to handle conflicts and required expertise.

Get in touch

Do you have any questions or would you like to give us feedback? We look forward to hearing from you!

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