Medical Devices Regulation in Practice from edX

Rules and regulations for medical devices in Europe are vital knowledge for anyone working in or interested in this increasingly regulated and dynamic field. Compliance with these regulations is not just an obligation, but also a key factor of success in the evolving world of medical device development.

Whether you are a user, engineer, or researcher, adherence to these regulations is essential. This course equips participants to not only meet these standards but also become valuable advisors in areas where medical devices are developed, designed, sold, or utilized.

This crucial guide will allow you to immerse yourself in the intricacies of European Medical Device Regulation, ISO standards, and local examples, to gain a profound and practical understanding of the legal landscape and its implications of the practical side of developing medical devices.

Upon completion, you will have the knowledge to identify and assess risks associated with medical device development and usage, and how to facilitate the effective and safe introduction of medical devices.

Overall, this knowledge forms the foundation for ensuring the safety and efficiency of medical technology, allowing participants to contribute meaningfully to the advancement of the field and ensure compliance with the latest regulations.

What's inside

Learning objectives

After taking this course participants should be able to:
• guarantee the safety and efficiency of medical technology developments and their application
• apply in-depth knowledge of laws and regulations regarding medical devices

• recognize and assess risks related to the development and use of medical devices
• propose design improvements for safety
• establish the safe and effective introduction of medical devices into a hospital

After taking this course participants should be able to:
• guarantee the safety and efficiency of medical technology developments and their application
• apply in-depth knowledge of laws and regulations regarding medical devices
• recognize and assess risks related to the development and use of medical devices
• propose design improvements for safety
• establish the safe and effective introduction of medical devices into a hospital

Syllabus

Week 1: Medical Devices Regulation

Introduction, definitions, classes of devices, overview of CE conformity procedures.

Week 2: Development of Medical Devices

CE conformity procedures in detail, Annex I, based on example device(s).

Week 3: Risk Analysis

ISO14971, ISO TR 24971, link to TU Delft’s Forensic Engineering method (as taught in the MOOC Forensic Engineering).

Week 4: Clinical Research

Art. 82 etc., Annex XIV & XV, ethical standards.

Week 5: Introduction and Implementation of Medical Devices in the Clinic

“Convenant Veilige Toepassing van Medische Hulpmiddelen” as example, selecting and introducing medical devices into the hospital, maintenance, repairs, in-house developments, custom devices.

Week 6: Final Assignment and Wrap-up

Choose from three devices: classify it and perform brief risk analysis, answer law-related questions, and take part in design improvement quizzes.

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Core Healthcare and Software Engineering audience

Taught by experts in their field

Focuses on the European market

Covers risk assessment and analysis, a key aspect of medical device development

Includes a final assignment where students apply the concepts learned in the course

Requires prerequisite knowledge in medical device development

Career center

Learners who complete Medical Devices Regulation in Practice will develop knowledge and skills that may be useful to these careers:

Medical Device Scientist

Medical Device Scientists play an essential role in developing and evaluating medical devices, ensuring compliance with regulations and standards. This course provides a deep understanding of Medical Device Regulation in Practice, enabling you to identify and assess risks associated with medical device development and usage, and to propose design improvements for safety. This knowledge is crucial for the successful development and implementation of safe and effective medical devices.

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Quality Assurance Manager

Quality Assurance Managers are responsible for developing and implementing quality systems to ensure that medical devices meet regulatory requirements and customer expectations. This course provides a solid foundation in European Medical Device Regulation, ISO standards, and local examples, equipping you with the knowledge and skills to effectively manage quality assurance in the medical device industry.

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Medical Writer

Medical Writers are responsible for creating technical documents, such as regulatory submissions, clinical trial protocols, and patient information leaflets. This course provides a deep understanding of Medical Device Regulation in Practice, including the legal and ethical requirements for medical device documentation. It also equips you with the skills to effectively communicate complex medical information to a variety of audiences.

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Regulatory Affairs Specialist

Regulatory Affairs Specialists are responsible for ensuring that medical devices comply with applicable regulations and standards. This course provides a comprehensive overview of Medical Devices Regulation in Practice, including the CE conformity procedures, risk analysis, and clinical research, enabling you to confidently navigate the regulatory landscape and guide medical device companies through the regulatory process.

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Clinical Research Associate

Clinical Research Associates are responsible for managing clinical trials, ensuring the safety and well-being of participants and the integrity of data. This course provides a solid understanding of the regulatory requirements and ethical standards for clinical research, enabling you to effectively manage clinical trials in compliance with Good Clinical Practice (GCP) guidelines.

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Product Manager

Product Managers are responsible for developing and managing the lifecycle of medical devices, from concept to market launch. This course provides a comprehensive overview of Medical Device Regulation in Practice, including the regulatory requirements for product development, risk management, and clinical evaluation. It also equips you with the knowledge and skills to effectively manage product development projects and ensure compliance with regulatory standards.

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Quality Control Inspector

Quality Control Inspectors are responsible for ensuring that medical devices meet quality standards and specifications. This course provides a deep understanding of Medical Device Regulation in Practice, including the quality control procedures and documentation requirements for medical devices. It also equips you with the technical skills and knowledge to effectively inspect medical devices for defects and ensure their compliance with regulatory standards.

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Clinical Engineer

Clinical Engineers are responsible for the installation, maintenance, and repair of medical devices in healthcare facilities. This course provides a solid understanding of Medical Device Regulation in Practice, including the safety and performance requirements for medical devices. It also equips you with the technical skills and knowledge to effectively troubleshoot and repair medical devices and ensure their safe and reliable operation.

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Sales Representative

Sales Representatives are responsible for promoting and selling medical devices to healthcare providers. This course provides a deep understanding of Medical Device Regulation in Practice, enabling you to effectively communicate the benefits and risks of medical devices to healthcare professionals and answer their regulatory questions. It also equips you with the skills to negotiate contracts and build long-term relationships with customers.

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Risk Manager

Risk Managers are responsible for identifying, assessing, and mitigating risks associated with medical devices throughout their lifecycle. This course provides a comprehensive overview of Medical Device Regulation in Practice, including the risk management requirements for medical devices. It also equips you with the knowledge and skills to effectively manage risk and ensure the safety of medical devices.

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Regulatory Compliance Officer

Regulatory Compliance Officers are responsible for ensuring that medical device companies comply with applicable regulations and standards. This course provides a comprehensive overview of Medical Device Regulation in Practice, enabling you to effectively implement and maintain compliance programs within medical device companies.

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Validation Engineer

Validation Engineers are responsible for ensuring that medical devices meet their intended use and performance specifications. This course provides a solid understanding of Medical Device Regulation in Practice, including the validation requirements for medical devices. It also equips you with the technical skills and knowledge to effectively validate medical devices and ensure their compliance with regulatory standards.

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Patent Attorney

Patent Attorneys specialize in obtaining and enforcing patents for medical devices. This course provides a deep understanding of Medical Device Regulation in Practice, enabling you to effectively advise clients on the patentability of medical devices and navigate the patent application process.

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Forensic Engineer

Forensic Engineers investigate accidents and failures involving medical devices. This course provides a solid understanding of Medical Device Regulation in Practice, including the risk analysis and safety requirements for medical devices. It also equips you with the technical skills and knowledge to effectively investigate medical device failures and identify the root cause of accidents.

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Healthcare Consultant

Healthcare Consultants advise healthcare organizations on a variety of topics, including medical device regulation. This course provides a deep understanding of Medical Device Regulation in Practice, enabling you to effectively advise healthcare organizations on compliance with regulatory requirements and best practices for medical device management.

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Medical Devices Regulation in Practice

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