Software plays an increasingly important role in both the development and use of medical devices. Do you know if your software qualifies as a medical device and what that entails? After completing the "best practices" training on Development and compliance of medical software according to IEC 62304, you will understand the relevant standards and guidelines and be able to comply with existing laws and regulations.
- Understand the relevant laws, regulations, standards, and guidelines that apply to your software
- Gain insight into establishing and maintaining intelligent documentation for this software
- Learn how to set up a practical development process for software products according to IEC 62304
About the training Development and conformity of medical software according to IEC 62304
Medical equipment often incorporates software, and standalone software for medical applications is increasingly available on the market. Did you know that the new Medical Device Regulation (MDR) in the EU requires certification via a Notified Body for many software products?
The training on Development and conformity of medical software according to IEC 62304 provides insights into all relevant laws, regulations, standards, and guidelines (such as IEC 62304, IEC 62366, MDR, ISO 13485, and ISO 14971). The practical application of IEC 62304 and MDR requirements is emphasized in this training, including discussions on many best practices, especially for agile software development. After the training, you will be able to determine whether engaging a Notified Body is necessary and establish a practical development process focused on software products.
This training is conducted internally within companies and is a continuation of the courses on CE marking of medical devices and Quality and Risk Management of medical devices. Completion of at least one of these modules is necessary as a prerequisite.
Program
- The basic principles and foundations of IEC 62304 and MDR
- Understanding when software qualifies as a medical device
- Classification of embedded software, standalone software, and apps
- Application of risk management and usability engineering during software development
- Establishment of a Certificate of Compliance based on essential requirements and standards
- Verification and validation of medical device software
- Traceability of software requirements
- Determining if a Notified Body is required before software can be placed on the market
- Labeling requirements for software products
- Integrated software development process based on ISO 13485 and IEC 62304
- Management of suppliers in the development of software products
Discover the possibilities to organize this course incompany
If you want to train several employees in your company, it is more interesting and cheaper to organize a course at your location. Good coordination with your company-specific situation and the deployment of highly experienced lecturers who have earned their spurs in practice is essential here. Mikrocentrum is CEDEO-recognized and guarantees the best quality.
Our training manager is happy to think along with you!
Are you interested in an incompany process? Our training manager Barend Blom will be happy to visit you without obligation.