Training

Training in Quality, Medical Devices, Audits, Cosmetics, Information Security and the Environment.

Our training organisation offers comprehensive and up-to-date programmes, specially designed to help you master key standards and regulations, particularly those relating to medical devices. Our training courses cover essential topics such as ISO 13485, ISO 14971, and European Regulations (EU) 2017/745 and 2017/746.

Our training areas:

Management systems

ISO 9001: Develop your quality management skills with the ISO 9001 standard to implement an effective Quality Management System (QMS).
ISO 31000: Risk management training according to ISO 31000 to identify and effectively manage risks.
ISO 22000: Food safety, learn how to implement a system that complies with ISO 22000.
ISO IEC 42001: Artificial intelligence, learn how to implement a system that complies with ISO IEC 42001.

Medical Devices: ISO 13485, ISO 14971 and Regulations (EU) 2017/745 and 2017/746

Our training courses in medical devices are designed to help you navigate the complex regulatory landscape of this sector, with a particular focus on ISO 13485, ISO 14971, and European regulations.

ISO 13485: This training is essential for any company involved in the manufacture, design or distribution of medical devices. ISO 13485 establishes the requirements for a Quality Management System specific to medical devices, guaranteeing compliance with regulatory requirements and patient safety.
ISO 14971: Find out how to apply the principles of risk management specifically to medical devices. ISO 14971 is the reference standard for identifying, assessing and controlling risks associated with the use of medical devices.
Regulations (EU) 2017/745 and 2017/746: These training courses will guide you through the requirements of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR). You will learn how to bring your medical devices into compliance with CE marking, technical documentation and post-market surveillance requirements.
IEC 62304: Development and maintenance of medical device software in accordance with this standard to ensure the safety and effectiveness of the software.
IEC 62366-1: Training on usability engineering, essential to ensure the safety of medical devices through user-centred design.

Audits: ISO 19011 Auditing management systems

Improve your internal and external auditing skills with ISO 19011 techniques and guidelines, particularly for assessing the effectiveness of quality management systems that comply with standards such as ISO 13485.

Cosmetics

ISO 22716: Discover good manufacturing practices for cosmetics to ensure product quality and safety in accordance with ISO 22716.
EFfCI: Learn the EFfCI (European Federation for Cosmetic Ingredients) requirements for the manufacture of cosmetic ingredients.

Information Security: ISO/IEC 27001

Master the ISO/IEC 27001 standard to establish, implement, maintain and improve an Information Security Management System (ISMS).

Environmental Management: ISO 14001

Learn how to implement an Environmental Management System (EMS) in accordance with the ISO 14001 standard to improve the environmental performance of your organisation.

Why Choose Our Training Courses?

Expertise: Our trainers have in-depth expertise in standards such as ISO 13485, ISO 14971, and European regulations (EU) 2017/745 and 2017/746.
Training Updated: Our programmes are continually updated to reflect the latest regulatory developments, ensuring that you receive cutting-edge training.
Practical Approach: Practical and tailored training, helping you to directly apply the knowledge acquired in your organisation to ensure the compliance and safety of medical devices.

To find out more about our training programmes and discover how we can help you strengthen your team's skills in quality and medical device regulation (including ISO 13485, ISO 14971, and Regulations (EU) 2017/745 and 2017/746), contact us today on our website.

Training

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