If you have any further questions contact us directly .
PS: Would you like another appointment? Get in touch with us! Or consider an In-house seminar .
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.
LEARN MORE
This training is the ideal preparation for the examination „Certified Professional for Medical Software“.
LEARN MORE
We are happy to discuss your specific files and subject them to a "quick check" upon request.
LEARN MORE
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).
Learn more
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.
LEARN MORE
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.
LEARN MORE
This seminar provides a compact introduction to the topic of development, quality assurance and approval of medical software.
LEARN MORE
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.
LEARN MORE
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.
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.
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.
Do you have any questions or would you like to give us feedback? We look forward to hearing from you!