ISO 13485 Medical device training courses

Discover ISO 13485 quality management and how it can improve your medical devices business. Our Understanding ISO 13485 Medical Devices course provides an overview of quality management system requirements.

• Explain the scope and the structure of the ISO 13485
• Describe the requirements of ISO 13485
• Explain how to understand and interpret and apply the requirements of the standard within an organization

Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

Build on the knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in your organization. 

Gain the knowledge and skills required to successfully host a MDSAP audit within your organization.Obtain in-depth knowledge about this new type of audit and how your organization is best prepared to support the completion of requirements within the allotted time. Discover how this program differs from the traditional ISO 13485 through its regulatory audit approach, the grading of nonconformities, and handling of the audit report.

• Interpret the requirements of ISO 13485 in the context of an audit
• Describe the purpose of a quality management system and explain the 8 principles of quality management
• Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011

Learn about the key requirements, concepts and the overall process for CE marking under the Medical Devices Regulation (MDR). The CE mark gives access to a market with 500+ million people.

This course will help you to implement the requirements of European Medical Device regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people.

This one-day intensive course enables you to gain a detailed understanding of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents.

This one-day course will help in gaining an understanding of the fundamental principles of pharmaceutical GMP and how compliance affects product quality. This course is intended to provide learners with an introduction to the fundamental principles of pharmaceutical GMP (PIC/S), the regulatory environment and product realization through market authorization, manufacturing, and lifecycle requirements.

This one-day intensive course enables greater understanding of the impact that ISO 14971:2019 has on the decision-making process when manufacturing medical devices.It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.