Training Courses

Medical Devices Specialized Training Courses

Increase your understanding of specific topics shaping the MedTech sector through our wide range of highly specialized courses.

Medical Devices Specialized Training Courses

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Become adept in numerous aspects of medical device manufacturing

Our training covers risk management, pharmaceutical, manufacturing and distribution as well as, clinical and performance evaluation, MDSAP, remote auditing, market surveillance processes and much more.

Whether in-person or virtual, our live sessions use accelerated learning techniques, securing your thorough comprehension through interactive workshops and lectures. Also see our on-demand e-learnings and free webinars for flexible learning options.

Visit our MDR Training Courses page for training on the European Medical Device Regulation.

Visit the IVDR Training Courses page for training on the European In Vitro Diagnostic Regulation.

Prepare yourself and your organization for the journey ahead

Understanding the evaluation processes and managing risk during every stage, from development and manufacturing to post-market medical devices, will allow you to avoid costly mistakes and put devices into the market more effectively.

Implement manufacturing and distribution best practices to improve competitiveness in the market and promote readiness for audits and documentation requirements to encourage confidence among stakeholders.

Popular medical devices specialized training courses

Our most popular courses are listed below with brief descriptions and links to our BSI Learning Marketplace for more details and to enroll.

Understand the impact that ISO 14971:2019 has on decision-making processes in medical devices manufacturing. Learn the key principles of risk management and how ISO 14971 interacts with quality system management (QSM) standards and device regulations (such as MDR and IVDR).

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Learn the clinical evaluation process, including key requirements, principles, development stages, documentation, and related post-market activities. This course contains interactive activities to test your knowledge on clinical evaluation.

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Gain the knowledge and skills required to successfully host a Medical Device Single Audit Program (MDSAP) within your organization. Understand the MDSAP structure, scope, and key differences from ISO 13485 audits.

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Get an understanding of key requirements for manufacturing process validation for medical devices as detailed in the European Medical Device Regulation (MDR) and ISO 13485:2016 requirements. The aim of the course is to increase your knowledge on evidence needed for manufacturing processes validation.

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Understand pharmaceutical GMP’s fundamental principles and key requirements. Get an introduction to Pharmaceutical Inspection Co-operation Scheme (PIC/S), regulatory environment, and product realization through market authorization, manufacturing, and lifecycle processes.

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Learn the key aspects of GDP for pharmaceutical manufacturers, wholesalers, secondary packagers, logistics companies, and distributors of pharmaceutical products. Find out how to maintain compliance in the distribution system.

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Get an understanding of the performance evaluation and clinical evidence for In Vitro Diagnostic (IVD) medical devices and their interaction with product development lifecycle and In Vitro Diagnostic Regulation (IVDR) requirements.

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Learn the requirements of the European medical device directives (90/385/EEC, 93/42/EEC, 98/79/EC), standards, and guidance documents to enable effective implementation of a post-market surveillance system. Post-market surveillance, including clinical follow-up, complaints, and vigilance handling, are vital in promoting compliance.

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Get an understanding of the key requirements for medical device technical documentation for the EU MDR 2017/745. Learn how to create documentation that demonstrates compliance to the MDR and meets notified body expectations, avoiding unnecessary delays to the certification process.

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Our training programs can help you and your organization inspire growth.

Do you have questions about our courses or enterprise programs? Contact our team at 1-800-217-1390 or submit an inquiry.

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