Introduction to the Development of Medical Software
In this training course, you will:
- Learn the conformity assessment procedures and the standards relevant to medical software.
- Have an overview of the regulatory framework.
- Familiarize with the requirements for the development of medical software throughout its entire life cycle.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
Medical device manufacturers whose products contain software or are a stand-alone software product, from the following areas:
- Regulatory Affairs
- Quality
- Project
- Risk management
- Product
- Management
- Service providers/suppliers in medical technology
- Medical Software Consultants
- Regulatory framework for medical software
- Decision-making aids for the classification of software as a medical device
- MDR/IVDR, Drugs & Cosmetics Act
- Classification of medical software (EU vs. FDA)
- UDI for Software
- Conformity assessment procedure
- FDA Premarket Submission: 510(k), PMA, Class I, Inspection
- Quality management according to ISO 13485, 21 CFR 820
- User Needs, System/SW Requirements, Development, Verification, Validation
- Corrective and Preventive Action (CAPA)
- Clinical Evaluation of Software
- Cybersecurity and data protection
- Special features of apps
- Overview of requirements for digital health applications
Understanding the requirements and regulations for the development process of medical devices is fundamental and a challenge for manufacturers. Our one-day seminar has been specially designed to give you an insight into this complex topic. You will get an overview of the regulatory framework and learn about the special features of placing software on the market as or for medical devices. In this way, you can enable your company to meet the highest standards in medical technology and know why this is important. Our experts will introduce you to the essential aspects of software development for medical devices. You'll gain insight into the needs of the industry and understand how to bring your business into compliance with applicable regulations. The seminar not only offers valuable knowledge, but also the opportunity to network and exchange ideas with other representatives of the industry. After the seminar, you will be strengthened to make important decisions in the field of medical device development.
- Learn about the requirements and understand the regulations.
- The contents of the seminar correspond to the current status of revision/harmonization.
- The seminar deals with internationally valid standards and is also suitable for implementation abroad
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Certificate of attendance from the TÜV SÜD Academy.