Risk Management of Medical Device Software According to ISO 14971
This course is certified by Exemplar Global.
In this training course, you will:
- Learn how to set up risk management of medical device software from development to application to patients.
- Kow how to create risk analyses for medical device software.
- Be aware of the requirements for the risk management process.
- Medical device manufacturers whose products contain software or are a standalone software product.
- Employees who are in charge of:
- Regulatory affairs management
- Quality management and risk management
- IT management
- Usability, requirements, system and software engineering
- Project and product management
- Corporate management
- Service providers and suppliers in medical device industry
- Consultants of medical software
- Risk management basics, definitions of terms
- Risk management process and ISO 14971
- Risk management analysis and documentation requirements
- Risk analysis for software:
- Scenario based risk analysis, SW-architecture, root-cause analysis,
- FTA, FMEA, IT security-analysis and third-party components
- Concept of EC/TR 80002-1:2009 - Medical device software Part 1:
- Guidance on the application of ISO 14971 to medical device software
- Risk assessment and risk management report
- Production and post-production activities, (configuration management, deployment, updates of databases, operating systems etc.)
- Change Management and risks
- Normative requirements according to ISO/EN ISO 14971, to FDA, to MDR and ISO/TR 24971: Medical devices - Guidance on the application of ISO 14971
Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent (standalone software) or driving or influencing the use of a device (embedded software as part of a medical device). The software has to be designed to ensure reliability and performance according to their intended use.
The establishment of an interactive risk management process across the product lifecycle is very essential for every manufacturer of medical device software in order to eliminate risks or minimize them as much as possible. Thereby, it is important to take applicable standards into account and consider various risk aspects, such as effects of software errors, negative interactions, aspects of the IT environment and IT security, safety-relevant functions and processes or verification- und validation steps.
In this seminar, you will learn the basic requirements for risk analysis of medical device software according to the applicable standards and you will be able to carry out a risk analysis and document the results properly. You will be able to assess the risks in your software and create a risk management report based on this.
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:
- Access to Exemplar LINK
- 12-months of exclusive benefits including:
- One self-coaching assessment
- Extended learning content
- Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
- Access to an exclusive LinkedIn Community
- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.Learn more about TÜV SÜD's Exemplar Global Accreditation today
This seminar addresses internationally valid standards. The contents of the seminar correspond to the current status of the revision/harmonization.
- Instructor-led in a virtual classroom
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion