Training Courses
Training Courses
Complete Guidance for Medical Device Compliance
MDSSPRO provides expertise in the form of training, auditing, and consultancy support to medical device organisations for full compliance with EU MDR and ISO requirements.Our training services offer practical and regulatory know-how, and grounding in real-life cases, tailored to the specific needs of your organisation, to ensure your team is compliant, confident, and prepared in every aspect of the medical device lifecycle
Risk Management Course
This one-day training course provides participants with an in-depth understanding of the requirements of EN ISO 14971, and applying it to medical device software. Participants will learn how to effectively identify, assess, and control risks to ensure the safety and compliance of the product.
Software Requirements Course
This one-and-a-half-day course provides an in-depth understanding of the requirements of IEC 62304 and applying these requirements to the development and maintenance of software as a medical device. This course will cover software lifecycle processes, documentation, as well as risk classification and risk management with respect to the expectations of the MDR.
Usability Requirements Course
This one-day course introduces participants to regulating usability engineering in accordance with IEC 62366 requirements, with the intent to improve the usability of a device and reduce the usability-related risks to users. This course focuses on usability and integration of human factors engineering into the design process to improve device safety and effectiveness.
Ethylene Oxide Sterilisation Training
This training provides a detailed understanding of the requirements of EN ISO 11135 for sterilisation using ethylene oxide (EO). The course includes validation of the EO sterilisation process concerning MDR and the MDD on qualification, testing, and documentation.
Irradiation Sterilisation Training
This 1-day training provides a clear understanding of EN ISO 11137-1 & -2 for sterilisation by irradiation. The course provides case studies so participants can build knowledge of validation, routine control, and batch release in compliance with the MDR/MSD.
Steam Sterilisation Training
This course is targeted at professionals working within the sterilisation of devices to provide some insight into EN ISO 17665-1 and its application to steam sterilisation. The course covers complete validation, routine controls, and requalification requirements for compliance with requirements from the MDR and MDD.
Clean Rooms Validation Training
This course discusses the requirements of the EN ISO 14644 series for validation of cleanrooms and environmental control. Participants will understand cleanroom classification, contamination control, monitoring, and general maintenance to comply with requirements from the MDR and MDD.
What Do We Do for You?
Reward your behaviour by delivering Quality, Integrity, and ComplianceAt MDSSPRO, we don’t just deliver training; we empower our clients by providing the knowledge, confidence, and technical expertise to maintain compliance long-lastingly. We pride ourselves on being accurate, open, and pragmatic so that every organisation trust us to do it efficiently and effectively.
Our commitment to quality service, continuous improvement and clients convenience has helped us become the trusted choice for the whole global medical device industry.
Our Achievements
Happy Students
Professional training courses
Let's Build Compliance Confidence Together
Partner with MDSSPRO and get your medical devices working to the highest regulatory compliance standards.
From customised training to experienced auditing, our team is here for you each step of the way to full MDR compliance.
