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

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.

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Risk Management

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.

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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 26.05.2020 (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.

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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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Usability, Requirements & IEC 62366

"Want to collect requirements quickly and systematically and create a lean, IEC-62366-compliant usability file?"

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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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IVDR for medical laboratories

In this seminar you will learn how to document and operate your in-house tests in an IVDR-compliant manner. You will learn to structure files and organize your schedule.

At the end of the seminar you will be able to classify your in-house test portfolio and create your individual IVDR schedule.

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Medical Device Consultant MPDG

The “Medical Device Consultant” or “Medical Device Advisor” is a role required by German and Austrian Medical Devices Act. Learn all about the tasks and duties of this role including updates according to the new German law MPDG!

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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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