Clinical Investigations in Practice – Based on MDR and ISO 14155
Safety and Market Access: Tailored Corporate Training for Medical Device Developers and Manufacturers
Request a quote
Clinical Investigations in Practice – Based on MDR and ISO 14155
Safety and Market Access: Tailored Corporate Training for Medical Device Developers and Manufacturers
Request a quote
A new era in clinical investigations – be prepared in time!
The market success and societal acceptance of medical devices fundamentally depend on their safety and performance for patients and users. Developers and manufacturers are responsible for demonstrating this not only through the technical performance of the product, but also with scientifically valid clinical evidence.
The Medical Device Regulation (MDR) (EU) 2017/745 requires that a clinical evaluation be performed for all classes of medical devices, based on solid evidence. A key element of this may be a clinical investigation, during which reliable data can be collected on the device’s safety and performance.
Why is this so important? The MDR requires that, as a condition for placing a device on the market, it can only obtain CE marking and remain on the market if clinical evidence proves that its benefits outweigh its risks. The application of the European harmonized standard ISO 14155 (Clinical investigation of medical devices. Good clinical practice) ensures that studies are ethical, scientifically sound, and reproducible, guaranteeing the reliability of data and the protection of study subjects. Improperly designed studies not only delay market entry, but can also cause serious financial and reputational damage.
The aim of the training is to help developers and manufacturers understand that clinical investigations are not administrative hurdles but strategic tools. They support proving product competitiveness, establishing trust among healthcare professionals and patients, and preventing market withdrawals or regulatory sanctions.
Why Choose Us?
✓ Preliminary needs and knowledge assessment
We thoroughly assess your company’s needs before the training. Our baseline program is then adapted to your organization’s specific requirements.
✓ Fast, flexible implementation
We also tailor the training format to the company’s needs: we offer online or in-person training, half-day, one-day or multi-day courses.
✓ Expert instructor(s) and exclusive training materials
We provide experienced lecturers who teach in a clear and practical manner. We provide customized training materials in both printed and digital form.
✓ Certificate – for participants and the company
At the end of the training, we assess knowledge acquisition and provide feedback on further areas of development.
- Individual certificates are issued based on the results of an online closing test.
- Company certificates include details of the training (duration, content, method) as well as aggregated participant results.
To Whom Do We Recommend the Training?
- Manufacturers and developers preparing for or participating in human clinical investigations
- Quality management and regulatory affairs professionals responsible for clinical documentation and compliance
- Clinical research professionals (e.g. investigators, coordinators) ensuring compliance with Good Clinical Practice (GCP)
- Medical device consultants and Contract Research Organizations (CROs) working on multiple client projects, seeking to update their knowledge of ISO 14155 requirements
Detailed information
- Introduction to the regulatory framework of ISO 14155
- Regulatory background according to MDR requirements
- The role of clinical investigations in clinical evaluation
- Design and approval of clinical investigations
- Responsibilities of investigational sites and principal investigators
- Patient safety and ethical considerations (informed consent, data protection)
- Documentation and reporting requirements
- Monitoring, audits, and regulatory inspections
- Common pitfalls, misunderstandings, and practical case studies
Course ID: 5006
Format: Training sessions are delivered either onsite at the client’s premises or online, depending on the client’s preference.
An onsite training ensures that our expert trainers provide exactly the knowledge your company needs. Participants also receive personalized answers to all their questions, making this format a highly effective platform for joint problem-solving and knowledge sharing.
NOBOVERSUM Zrt. undertakes to:
- Develop a tailored training program and provide expert trainers based on the client’s needs
- Deliver the training materials in both electronic and printed formats
- Ensure that trainers answer all participant questions in full