Best of in English

This two-day seminar is designed for English speaking professionals that have to navigate and comply with the complex medical devices regulations and approval processes.

The seminar is a best-of Johner Institute seminars that has been compiled for an English-speaking audience.

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CPMS (English)

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

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Risk Management and ISO 14971 (English)

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 (English)

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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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. 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.

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