Training Programs Professionals

Available Training Courses

Our training offerings include:

• Introduction to EN ISO 13485: Fundamentals of quality management systems for medical devices.
• Practical Implementation of EN ISO 13485: Hands-on guidance for integrating ISO 13485 into your organization.
• EN ISO 13485 Internal Auditor: Developing skills to conduct effective internal audits.
• MDR (EU 2017/745): Overview of the Medical Device Regulation requirements.
• Practical Implementation of MDR: Strategies for achieving and maintaining MDR compliance.
• Practical Implementation of IVDR: Strategies for achieving and maintaining IVDR compliance.
• Post-Market Surveillance & Clinical Follow-Up: Managing post-market obligations effectively.
• Person Responsible for Regulatory Compliance (PRRC): Understanding the role and responsibilities under MDR.
• Risk Management per EN ISO 14971: Implementing risk management processes for medical devices.
• Usability Engineering per IEC 62366: Enhancing device usability and user interface design.
• Biocompatibility per ISO 10993: Assessing and ensuring biological safety of medical devices.
• Successful 510(k) Submissions: Navigating the FDA premarket notification process for U.S. market entry.

Excellence Package

Enhance your training experience with our Excellence Package, which includes an additional day focused on:

• Effectiveness checks of implemented processes.
• Gap assessments to identify areas for improvement.
• Risk management activities tailored to your new device.
• Practical application of the learned theory to real-world scenarios.

This package is designed to provide personalized support, ensuring that your organization can effectively apply the training insights.