Delivering Features at High Velocity in Regulation Intensive Environments

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We use modern development practices to document the code and the APIs exposed by our microservices. We use tools to automatically generate developer portals. Is this enough when developing software used in a regulated domain? This talk introduces the audience to the particularities of developing medical device software and the regulatory landscape that you must comply with. I’ll focus on the processes and culture that facilitate compliance, without damaging the team velocity and spirit.

Software

Delivering Features at High Velocity in
Regulation Intensive Environments
Vlad Știrbu
CompliancePal
Nordic APIs Platform Summit, Stockholm
23.10.2018

CompliancePal
What is regulation intensive environment?
Organizations have to adhere to laws,
regulations, guidelines and specifications
relevant to their business.

CompliancePal
Laws and regulations
HIPAA: Health Insurance Portability and Accountability Act
GDPR: General Data Protection Regulation
MDR: Medical Device Regulation

CompliancePal
Guidelines and specifications
ISO 13485: Quality management systems
ISO 14971: Application of risk management to medical devices
IEC 62304: Software life cycle processes

CompliancePal
Software development processes and activities
https://www.medicaldesignbriefs.com/images/stories/MDB/2017/features/MDB-1017-p24_fig1.jpg

CompliancePal
Software safety classification
death or serious injuryC
thorough design documentation
and testing
non-serious injuryB design documentation and testing
no injury or damage to healthA
design documentation and testing
not required

CompliancePal
Manifesto for agile software development
Individuals and interactions over processes and tools
Working software over comprehensive documentation
Customer collaboration over contract negotiation
Responding to change over following a plan

CompliancePal
Compliance
Officer
The regulated environment agile development
Product backlog Sprint backlog Sprint Product
Documentation
Sprint
Snapshot
Risk management
Documentation
Architecture/
Software/API
Archeology

CompliancePal
Agile compliance
Git CompliancePal
Developer Compliance
Officer
commit
notification
status
Team chat
problems
view
Backlog
compliance issues
status

CompliancePal
“transition... tasks from being implicitly
performed to explicitly scheduled”
Does Agile Kill Innovation, Jan Bosch
https://www.linkedin.com/pulse/does-agile-kill-innovation-jan-bosch/

CompliancePal
Agile compliance practices
compliance checks on code commits
continuous risk management
automation
documentation sprint

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Alluxio Monthly Webinar May. 14, 2024 For more Alluxio Events: https://www.alluxio.io/events/ Speaker: - ChanChan Mao (Developer Advocate, Alluxio) - Bin Fan (VP of Technology, Alluxio) Running AI/ML workloads in different clouds present unique challenges. The key to a manageable multi-cloud architecture is the ability to seamlessly access data across environments with high performance and low cost. This webinar is designed for data platform engineers, data infra engineers, data engineers, and ML engineers who work with multiple data sources in hybrid or multi-cloud environments. Chanchan and Bin will guide the audience through using Alluxio to greatly simplify data access and make model training and serving more efficient in these environments. You will learn: - How to access data in multi-region, hybrid, and multi-cloud like accessing a local file system - How to run PyTorch to read datasets and write checkpoints to remote storage with Alluxio as the distributed data access layer - Real-world examples and insights from tech giants like Uber, AliPay and more

Alluxio Monthly Webinar | Simplify Data Access for AI in Multi-Cloud

Alluxio, Inc.

Workshop 1. Architecting Innovative Graph Applications Join this hands-on workshop for beginners led by Neo4j experts guiding you to systematically uncover contextual intelligence. Using a real-life dataset we will build step-by-step a graph solution; from building the graph data model to running queries and data visualization. The approach will be applicable across multiple use cases and industries.

Workshop - Architecting Innovative Graph Applications- GraphSummit Milan

Neo4j

Computation is increasingly constrained by power. With each advancement in the manufacturing process, a decreasing percentage of the CPU can operate at full capacity, leading to the emergence of the term 'dark silicon'. This trend necessitates techniques that utilize chip area to optimize power efficiency through specialized accelerators. The presentation will outline key concepts that led to the dark silicon such as Moore’s law and breakdown of Dennard scaling, followed by an overview of current and upcoming CPU accelerators. The focus will then shift to vector units and the specifics of vector programming. Attendees will be introduced to registers, a range of vector operations, and methods to develop branchless algorithms such as sorting networks. The session will conclude with an overview of the new Java Vector API and how it was already picked up by projects to do AI inference (Llama 2) and vector search (AstraDB and Cassandra).

[GeeCON2024] How I learned to stop worrying and love the dark silicon apocalypse

Tomasz Kowalczewski

“I think, therefore I am.” From the moment we arrived on this chaotic planet, we began learning (even before that, actually, but let’s ignore that for now). Every day, we learn: good patterns, bad patterns—the brain doesn’t differentiate! However, for us to simply say, “I learn while I do,” might be a bit too easy. Or, at least, one might wonder if it’s the most efficient and satisfying way to learn. During this talk, you'll learn how our brains absorb and retain new information. Afterward, we’ll explore how you can create the best conditions and environment for your specific learning needs. Among other things, we’ll cover what has scientifically been proven to be the ideal learning blocks regarding time and content. We’ll discover how to create an environment that improves our focus and remain in the “flow.” And we’ll discuss the profound impact of AI on the entire learning landscape. As we navigate the ever-changing landscape of software development, this knowledge will empower you to enhance your own learning curve and, just as importantly, extend a helping hand to those on their own learning path.

Wired_2.0_CREATE YOUR ULTIMATE LEARNING ENVIRONMENT_JCON_16052024

SimonedeGijt

A Deep Dive into Secure Product Development Frameworks.pdf

ICS

UNI DI NAPOLI FEDERICO II - Il ruolo dei grafi nell'AI Conversazionale Ibrida

Neo4j

Nearly a decade ago, a small group of menders (and one maker) found community with each other at a conference and Legacy Code Rocks was born. Since then, the Legacy Code Rocks community has grown to over 1000 people, 150 podcast episodes, a weekly meetup and of course, MenderCon. In this talk, Andrea Goulet, the maker who kindled the spark, will take us back to those early days and reflect on how the bedrock of the Legacy Code Rocks community has always been creating a sense of belonging. Compassion and empathy are at the core of being a mender. Mending is caring deeply, seeing potential, and being willing to work through the frustration of making things better one small step at a time. This commitment to helping others feel seen instead of shame is why the Legacy Code Rocks community is so special — and it’s exactly why having the heart of the mender is what our world needs now more than ever.

Community is Just as Important as Code by Andrea Goulet

Andrea Goulet

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Modeling languages are generally applied for developing systems and software – both internally, with domain-specific languages, and with standardized languages targeting a general purpose and a wide audience. Way too often these languages are weakly created and defined leading to poor quality: Language definitions tend to contain errors and inconsistencies; notations do not recognize the communication and problem-solving needs of humans; standardization organizations push exchange formats that do not fully work and offer certificates that do not measure mastery of the language. We describe common problems in language development and point them out with examples from known cases. To overcome these problems, we suggest several solutions to improve language development, including using modeling languages specifically designed to define modeling languages, continuous testing and prototyping, and keeping language users in the loop.

What Goes Wrong with Language Definitions and How to Improve the Situation

Juha-Pekka Tolvanen

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