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.
The crash course not only for medical device software developers: Learn to know the regulatory framework and the software specific requirements of MDR, MDD, IEC 62304 and FDA. You will understand how to work agile, effectively and compliant.
The seminar “usability, requirements and IEC 62366" provides you with all the knowledge to comply with the law (also with FDA), so you can create the proper application file and develop usable medical products.
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 seminar is designed for English speaking professionals that have to navigate and comply with the complex medical devices regulations and approval processes.
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.
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.