Training
Our professional training and development services are designed to provide your team with essential knowledge in medical equipment, quality systems and regulatory matters. We offer personalized on-demand programs in both practical and theoretical formats, both in person and live online, ensuring that your organization achieves operational excellence and regulatory compliance.
Post-Market Surveillance (PMS)
and Post-Market Clinical Follow-up (PMCF) for Medical Devices
This intensive course allows participants to gain professional training in understanding the requirements for Post-Market Monitoring of medical devices in accordance with MDR 2017/745.
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Project Management
of Medical Devices
This intensive course allows participants to gain professional training in understanding the dynamics of project management, learning about management tools and their applications, including the execution of project stages and documentation in accordance with the requirements of ISO 13485:2016 and RDC 665/22.
- Project Opening/Planning ( Predictive vs. Agile Approach)
- Project Methods (Waterfall, V-Shape, Precedence Diagram, Critical Path, Critical Chain, Kanban, Scrum, PMBOK)
- Project Performance Measurement
- Project Input and Output
- Project Verification and Validation
- Critical Analysis and Change Control
- Project Transfer and Release
- RHProj x RMP x RHP
Safety and performance of medical devices IEC 60601-1
This intensive course allows participants to gain professional training in understanding the safety and performance requirements of the general standard ABNT NBR IEC 60601-1:2010 + Amendment 1:2016 + Amendment 2:2022 in order to apply it to analyze, specify, develop, verify and validate requirements for medical devices, mitigating risks and optimizing the certification process.
Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) for IVD.
This intensive course allows participants to gain professional training in understanding the requirements for Post-Market Monitoring of in vitro medical devices according to MDR 2017/746.
Electromagnetic Compatibility of Medical Devices IEC 60601-1-2
This intensive course allows participants to gain professional training in understanding the safety and performance requirements of the ABNT NBR IEC 60601-1-2:2017 + Amendment 1:2022 standard in order to apply it to analyze, specify, develop, verify and validate requirements for medical devices, mitigating risks and optimizing the certification process.
Usability and User Experience Design for Medical Devices
This intensive course allows participants to gain professional training in understanding the principles of User Experience Design (UX) to create products that provide meaningful and relevant experiences to users, including aspects of branding, design, usability and function, as well as the requirements of the IEC 60601-1-6 and IEC 62366-1 standards, in order to apply them to analyze, develop, verify and validate the usability, related to the safety of medical devices.
Medical Device Risk Management
This intensive course provides professional training for participants to understand the requirements of the ISO 14971:2019 standard and the ISO/TR 24971:2020 guide in order to apply them in the design, development, manufacturing, usability, clinical evaluation and post-market monitoring throughout the life cycle of medical devices.
Preclinical Evaluation
of Medical Devices
This intensive course provides an overview of the main preclinical evaluation processes for medical devices, allowing participating professionals to understand the dynamics of this process and plan the execution of these validations.