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Experts Talk: Automotive SPICE® Level 3 and Beyond with codeBeamer ALM

On 14 October 2020, Intland Software’s Functional Safety Expert Szabolcs Agai gave a talk at the MethodPark Process Insights USA virtual conference. Watch this recording of his talk to explore how Application Lifecycle Management supports the delivery of automotive technology in compliance with ISO 26262 and ASPICE.
Recorded Feb 26 2021 32 mins
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Szabolcs Agai
Presentation preview: Experts Talk: Automotive SPICE® Level 3 and Beyond with codeBeamer ALM

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  • Patterns of Agile Success in Medical Device Development Jun 17 2021 1:00 pm UTC 60 mins
    Dr. Andreas Birk | Founder and principal consultant of Software.Process.Management
    Agile approaches offer many benefits for product development in the regulated domain of healthcare technology. What specific and proven best practices contribute to the success of Agile? What important experiences do healthcare companies report?

    This webinar presents case studies and experience reports from the agile development of MedTech products. It shows possible practical solutions to overcome the perceived incompatibility between agile methods and regulatory constraints. Participants will receive orientation and evidence-based guidance to make their agile product development a success.

    -What benefits do healthcare companies experience when moving to agile product development?
    -What are the key agile success strategies of organizations in the regulated MedTech domain?
    -How can agile organizations overcome regulatory challenges and manage product success?
  • Roundtable Discussion: Agile in Medical Technology May 27 2021 2:00 pm UTC 62 mins
    Sarb Singh-Kaur, VP of Software Engineering | Alan Schachtely, Senior Director, SW Engineering | Jared Miller, Co-Founder&CTO
    Watch this on-demand recording of Intland Software’s Roundtable Discussion featuring experts representing innovative medical device companies. Titled Agile in Medical Technology, this discussion covers the challenges and benefits of applying Agile practices in the development of cutting-edge medical technology.
  • Accelerating Delivery & Reducing the Cost of Complaince for Embedded Software May 11 2021 1:00 pm UTC 48 mins
    Stephen DiCamillo Technical Marketing and Business Development Manager, LDRA | Jaikumar Daniel Pre-Sales Consultant, Intland
    Each year, the amount and complexity of embedded software in safety and security-critical systems continues to grow. At the same time, technologies such as Artificial Intelligence, machine learning, Internet of Things, and autonomous controls are being deployed to make products ‘smarter’ while making it more challenging to ensure they are safe and secure. The combination of the growth of embedded software and the growth of safety and security requirements is putting a strain on traditional systems and software development processes and tools.

    During this webinar, we will explore key areas of improvement, explain why they are important, and show how they can accelerate delivery and reduce the cost of compliance for critical embedded software.

    Join this webinar to understand how tooling and processes need to be enhanced and improved to support:

    Cross-discipline Collaboration:
    -Traceability and Transparency Throughout the Development Lifecycle
    -Rapid Iterative Development
    -Insightful Impact Analysis and Change Management
    -Efficient and Predictable Tool Qualification
  • Medical Device Risk Management & ISO 14971 Compliance with Roche May 5 2021 1:00 pm UTC 60 mins
    Mirko Klingauf Systems Engineer | Roche Diagnostics
    Roche is adapting codeBeamer ALM for its Application Lifecycle Management processes including requirements, test, risk, and defect management. Mirko Klingauf, a Systems Engineer at Roche Diagnostics in Switzerland, is tasked with the implementation.

    In this webinar, he will talk about the implementation of ISO 14971:2019 – Application of Risk Management for Medical Devices in codeBeamer ALM.

    During the webinar, we’ll touch on the following topics as well as receiving audience questions:
    -Using codeBeamer ALM to manage requirements, tests, risks, and defects
    -Decomposing risk elements into codeBeamer trackers
    -Mapping the risk status model to the risk assessment process
    -Configuration and release management of risks
  • Webinar with Volkswagen: ECU Software Development with codebeamer May 4 2021 1:00 pm UTC 31 mins
    Dr. Stefan Bussmann, Business Process Management SW & Homologation, Group IT, Volkwagen AG
    In his talk, Volkswagen’s Dr. Stefan Bussmann (VW AG) will cover the IT aspects of developing ECU software using codeBeamer ALM. The VW Group has implemented Intland’s platform to manage requirements and product testing in their ECU development processes. Dr. Bussmann’s insightful talk covers aspects of deployment, integration, security, and data privacy based on VW’s company-wide rollout of codeBeamer ALM!
  • Agile Practices for Medical Device Development Apr 29 2021 1:00 pm UTC 60 mins
    Dr. Andreas Birk is the founder and principal consultant of Software.Process.Management.
    Medical device development can benefit much from agile approaches to software and product development. However, regulatory constraints and other characteristics of health tech development necessitate the use of advanced Agile workflows and practices.

    This webinar presents and explains specific Agile practices, i.e., methods, workflows, templates etc, that are particularly important for medical device development. Examples are: using a Definition of Done for managing regulatory constraints, establishing traceability between agile work items, and building compliance incrementally.
  • Adaptive Project Execution in High-Risk Industries Apr 27 2021 1:00 pm UTC 64 mins
    Bence Toth, Industrial Automation Local Business Line Manager Hungary, ABB | Kalman Keresztesi CEO & Pharma Expert, Controsys
    Due to stringent regulations, project management in high-risk (safety or mission-critical) industries is a daunting task. Communication with numerous internal and external stakeholders, collaboration with subcontractors, and the management of changes all pose challenges in terms of ensuring transparency in project management and documentation.

    Join experts from leading global technology company ABB and industrial automation company Controsys as they describe how the application of integrated ALM can help tackle project management challenges in the pharmaceutical, nuclear power plant, and oil and gas industries. Through real-life use cases, ABB’s expert will explore how codeBeamer ALM has helped maximize team performance to stay on project schedules and achieve compliance with standards such as GAMP® 5, IEC 61508:2010 Part 3 Section 7.4.4, IEC 26262, and IEC 62138.
  • Using ALM to Drive Automotive Innovation: ASPICE and ISO 26262 Compliance Apr 22 2021 1:00 pm UTC 62 mins
    Andreas Pabinger | Szabolcs Agai | Daniel Jaikumar
    For years, Intland Software has been working with leading developers of mobility technology at the forefront of automotive innovation. The company’s tools are used by the top 5 German OEMs to ensure process maturity & regulatory compliance. In this webinar, we explore how Intland’s products unify the automotive ecosystem, and how the company’s tools help carmakers and suppliers streamline ASPICE and ISO 26262 compliance. The webinar concludes with a Q&A session.

    The webinar's agenda:
    -Introducing Intland Software’s footprint & partners in India
    -Intland Software’s role in supporting developers of automotive technology
    -Flexibility in platforms and business models to suit automotive needs
    -Traceability, Compliance, and FUSA with Intland’s ASPICE and ISO 26262 Template
  • Next Generation Project Validation Processes in Pharmaceutical Development Apr 15 2021 1:00 pm UTC 47 mins
    Gábor Papik - Gedeon Richter | Kalman Keresztesi - Controsys
    Gedeon Richter is a multinational pharmaceutical and biotechnology product developer. The company faced systems validation challenges of its new computerized manufacturing sites and projects. In cooperation with global pharma automation expert & system integrator ABB they realized a project to complete validation processes with reduced effort and within a shorter timeframe, ensuring full GAMP® 5 compliance.

    In this webinar, experts from Gedeon Richter and Controsys will discuss the lessons learned in applying codeBeamer ALM to achieve efficient, fast, and fully paperless systems validation. The discussion will cover questions of documentation, traceability, and maintaining historical data in a digital system.

    During the conversation, we’ll touch on the following topics as well as receiving audience questions:

    -What are the main challenges in the validation of pharmaceutical systems and what is the primary need driving the development of these systems?
    -At what stages of the project do major validation challenges arise?
    -How can pharmaceutical companies collaborate efficiently with system integrators in validation processes?
    -How does a pharmaceutical company benefit in the short to medium term by applying a software-based validation solution?
    -How have responsibilities and communication processes changed since the transition from paper-based systems?
  • Improving the Efficiency of Product Line Engineering for Requirements Management Recorded: Mar 31 2021 36 mins
    Paul Clements | BigLever Software & Daniel Jaikumar | Intland Software
    For developers of complex product families, managing product line diversity is a challenge. Inefficiency in managing commonality and variations in product requirements leads to wasted resources and long cycle times.

    Join Intland’s webinar with an invited expert from BigLever Software, the long-standing leader in Product Line Engineering, to learn about a novel approach to realizing efficiencies through synergies in ALM and PLE.
  • ISO/PAS 21448 (SOTIF) in the Development of ADAS and Autonomous Vehicles Recorded: Mar 23 2021 72 mins
    Szabolcs Agai
    As the innovation of emergency intervention, ADAS (Advanced Driver Assistance Systems), and self-driving technologies progresses, the automotive industry is already formulating ways to ensure the safety of these solutions in our vehicles. ISO/PAS 21448:2019 (SOTIF) is the first universal standard addressing the safety of the intended functionalities in our vehicles.

    Join this webinar to get familiar with the concept of “Safety of the Intended Functionality” (SOTIF) and the relationship between ISO 26262:2018 and ISO/PAS 21448:2019. This practical session will help you understand how to design and configure codebeamer to address SOTIF requirements. Sign up to learn configuration tips & tricks and to gain early access to our SOTIF-ready workspace free of charge!

    The webinar’s agenda:

    -Introduction to SOTIF (ISO/PAS 21448:2019) and its relation to ISO 26262
    -Designing and configuring a codeBeamer workspace for SOTIF
    -Early access to SOTIF workspace
  • Roche's Best Practices on Managing Electronic Records, Signatures, Scope Items Recorded: Mar 10 2021 58 mins
    Maximilian Poprawe
    Following the success of his keynote talk at the Intland Connect Annual User Conference 2020, we’re excited to offer a best-of-both worlds rerun with a Live Q&A featuring Max Poprawe, Product Manager Requirements Management and Testing, Roche Diagnostics!

    In this humorous yet insightful webinar, Roche’s Max Poprawe (and his guest Rita the Requirement) shares Roche’s best practices for managing Design History Files in a digital environment. This session covers various topics of managing electronic records, e-signatures, and scope items using cutting-edge software tools.

    At the end, Max will join us live for the Q&A session. Learn all about taking your digital record keeping practices to the next level, and have your questions answered by Roche’s requirements & testing expert!
  • Approaches to Agile in Medical Device Development Recorded: Mar 4 2021 72 mins
    Dr. Andreas Birk
    Medical device development with its regulatory requirements is often viewed unsuited for Agile methods. There does seem to be a natural tension between commonplace Agile practices and regulatory compliance requirements in MedTech. However, these challenges can be overcome, unlocking Agile’s potential to bring important benefits to the development of medical devices.

    This webinar highlights key characteristics of medical device development that must be considered to guide the successful implementation of Agile. During this session, we’ll present important strategies that support MedTech organizations on their journeys to Agile, helping them make the most of Agile's enormous potential!

    -Does Agile contradict regulated product development?
    -Advantages of Agile for medical device development
    -Challenges of Agile adoption in MedTech environments
    -Agile success strategies for medical device development
  • Experts Talk: Automotive SPICE® Level 3 and Beyond with codeBeamer ALM Recorded: Feb 26 2021 32 mins
    Szabolcs Agai
    On 14 October 2020, Intland Software’s Functional Safety Expert Szabolcs Agai gave a talk at the MethodPark Process Insights USA virtual conference. Watch this recording of his talk to explore how Application Lifecycle Management supports the delivery of automotive technology in compliance with ISO 26262 and ASPICE.
  • Challenges of ADAS Innovation in Mobility Development with AImotive Recorded: Feb 24 2021 54 mins
    Szabolcs Agai; Szabolcs Janky
    In the development of mobility technology, focus is turning from hardware to the innovation of complex software such as Advanced Driver Assistance Systems (ADAS). As software’s role increases, carmakers are striving to deliver their latest innovations to users while maintaining safety and security.
    A passenger car’s USP today lies in software content, innovation, and safety. The continuous integration and deployment of software is becoming more and more of a challenge.

    Join our webinar to learn more about:

    -How self-driving technologies are evolving towards level 3 autonomy
    -Strategies to ensure software safety in mobility development
    -How the standardization environment is changing to develop regulations applicable to self-driving technologies
    -What market trends this technology disruption is contributing to, and how the market is changing as new players enter the competition
  • Balancing Innovation, Risks, and Compliance in Medical Device Development Recorded: Jan 20 2021 36 mins
    Szabolcs Agai | Safety & Regulatory Expert, Intland Software
    Developers of medical devices and other medical technology are in a difficult spot. Not only are they operating at the cutting edge of technology innovation, an inherently risky business. But they must also meet regulatory compliance requirements of various local or international standards. To top it off, they have to juggle those aspects while outpacing competitors in order to stay profitable.

    Watch this Experts Talk webinar with Intland Software’s Functional Safety expert and Quality Consultant Szabolcs Agai. In this webinar, Intland’s expert provides insights on striking that delicate balance between fast innovation, adequate risk management, and stress-free regulatory compliance.

    Intland Software’s expert shares practices to improve your teams’ performance in the delivery of advanced medical technology. In this webinar, we also demonstrate how Intland’s Medical Software Engineering Template helps you tackle risks, accelerate product development, and simplify compliance audits.

    - Implementing a risk-focused, fully compliant medical device innovation process
    - Integrating quality, product development, and regulatory compliance aspects in medtech delivery
    - Identifying, analyzing, reporting on, and managing risks and hazards in compliance with ISO 14971
    - Best practices of medtech lifecycle management based on our expert’s field experience
Live and on-demand webinars for safety-critical software professionals
Our regular webinars feature Intland's domain-expert partners, invited professionals from leading digital product development companies, and Intland's own experts. These live sessions (as well as their on-demand recordings) cover a variety of topics related to software-heavy product development in safety- or mission-critical industries. Join our webinars for cutting-edge insights & best practices from industry leaders. Find out how leading innovators are cutting product development time and costs, and how they use Application Lifecycle Management to gain a competitive edge.

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