Compliance
Excellence Day 2026
On October 6, we’re once again hosting our popular Compliance Excellence Day in Kista! We warmly welcome you to a packed day of engaging presentations and networking.
AI in Life Sciences—From Uncertainty to Practical Reality
Regardless of our stance on AI, it is already having a significant impact on how we work in LifeScience compliance, and that impact will only grow. The AI Act categorizes us as providers and deployers. Whether your company is a provider or not, we will all be deployers at the very least—whether we like it or not. This entails new requirements for how we handle AI from a regulatory, technical, and operational perspective.
At the same time, many companies face the same challenge. The technology exists, but uncertainty regarding the interpretation of regulations, validation, and liability is slowing down progress. That is why we are dedicating this year’s Compliance Excellence Day entirely to AI in practice.
What's happening today?
Throughout the day, we’ll focus on where the industry actually stands right now, including through exclusive insights from Plantvision’s own AI Readiness Survey. The survey examines how Swedish life sciences companies view AI today, where they are in their AI journey, and what the results reveal about the path forward.
We’ll review the current regulations and clarify how the AI Act aligns with the MDR and IVDR in practice: which requirements apply, what overlaps arise, and what this overlap specifically means for medical device companies.
We also propose an approach to validating AI modules in computerized systems, with practical methods and strategies for managing the next generation of computerized systems. And we highlight cybersecurity as the critical obstacle it truly is and explain how to build robust protection that enables—rather than limits—AI adoption.
We also explore the growing role of AI agents in compliance work, what they can do in a highly regulated environment, and what frameworks are needed at Location.
Lectures, discussions, and networking
Compliance Excellence Day is more than just an educational program. It is a forum where experts, specialists, users, and decision-makers share experiences, challenges, and solutions that work in the real world.
Our goal is for you to leave the event with concrete insights, new perspectives, and valuable contacts regarding some of the most critical compliance issues in the life sciences sector today. Welcome!
Meet our partners
During the day, you will also have the opportunity to meet some different organizations that we work with.
Agenda
Throughout the day, you can simply choose which of the two presentations in each time slot you’d like to attend. (We reserve the right to make changes to the agenda.)
8:30 a.m. Welcome reception
9:20 a.m. Welcome Remarks
9:30 a.m. Block 1
Regulatory Framework for AI in the Life Sciences—What Are the Current Rules as of Fall 2026?
Mattias Anderson, Plantvision
In this presentation, we take a closer look at the regulatory landscape for AI in the life sciences. We’ll review which regulations have already been adopted, which ones are in the works, and what we actually know at this point. The focus is on providing a clear picture of the current situation and a practical understanding of how you can address these requirements in your business. We’ll discuss both the opportunities and challenges of AI in the life sciences and clarify what you, as a decision-maker, really need to keep track of—both today and in the years ahead.
AI and Standardization
Pernilla Andrée, SIS (Health, Healthcare & Social Services)
Pernilla Andrée has many years of experience in the medical device industry, with a background in both electrical safety testing of medical devices and the industry association Medtech. She currently works at SIS, where she leads standardization committees that develop and influence future standards in the healthcare sector, both nationally and internationally.
During the presentation, you will gain insight into current standardization projects related to the Internet of Things ( Medtech ) and artificial intelligence (AI), as well as an understanding of how artificial intelligence is changing the landscape for future standards.
10:30 a.m. Block 2
How is AI used in the life sciences today?
Mattias Anderson, Plantvision
Mattias Anderson summarizes the findings from Plantvision’s AI Readiness Survey. We examine how Swedish life sciences companies view AI today, where they stand in their AI journey, and what opportunities, challenges, and regulatory issues are shaping the path forward. A current snapshot of the industry’s AI maturity and the path toward the AI-driven businesses of the future.
Panel discussion
Moderator: Pascal Skoglund, Plantvision
What does the CE marking process look like, and what lies ahead? Gain knowledge and insights from Notified Bodies on how to ensure your products meet the requirements—and on how the MDR/IVDR revision, stricter cybersecurity requirements, and AI are changing the playing field going forward.
11:15 a.m. Lunch
12:15 p.m. Block 3
Compliance Officers—Opportunities and Limitations
David Buresund, Regnora & Mattias Anderson, Plantvision
What exactly is an AI agent, and how can it create value in a regulated business? In this session, David Buresund from Regnora will provide an introduction to agent technology, followed by concrete examples of how AI agents can be used in compliance. Through real-world case studies, we’ll show how the technology can strengthen compliance, streamline workflows, and create business value.
data integrity In the AI Era—More Relevant Than Ever
Daniel Johansen, Plantvision
How can we ensure data integrity when AI is introduced into a GxP environment? AI fundamentally reinforces these requirements, as the integrity of training data, validation data, and system output must be ensured. Daniel Johansen presents a view of AI as a “human-computer system,” with a focus on managing bias, data governance, and compliance.
1:15 p.m. Block 4
Validation of AI-Based GxP Systems
Carl Adelsköld & Anders Christensen, Plantvision
How can you ensure that AI-based systems meet regulatory requirements in a GxP environment? Carl Adelsköld and Anders Christensen present a risk-based approach to AI validation with a focus on compliance.
Cybersecurity—The Hidden Obstacle to AI Adoption
Henrik Fält Padoan & Magnus Eriksson, Plantvision
How can organizations implement AI without losing control over risks, compliance, and information security? Magnus Eriksson and Henrik Fält Padoan highlight how AI is changing the risk landscape and, drawing on NIS2 and other sources, demonstrate how cybersecurity, quality, and governance together create the conditions for a secure and effective AI adoption.
2:00 p.m. Coffee break
2:30 p.m. Block 5
Ylva Williams, CEO, Stockholm Science City
AI, rapid advancements in knowledge, and increasing demands are changing the business landscape. Ylva Williams will discuss how strong innovation ecosystems and innovation districts can enhance companies’ competitiveness through proximity to knowledge, expertise, networks, test environments, and collaboration partners. It also highlights how compliance can evolve from a control function to an enabler of responsible innovation, using Stockholm–Uppsala and Hagastaden as examples.
Cybersecurity and AI Compliance for Connected Medical Devices
Richard Skalt, TÜV SÜD
Richard Skalt, Advocacy Manager at TÜV SÜD’s Global Cybersecurity Office, breaks down the evolving compliance landscape for manufacturers of connected medical devices, covering: the AI Act following the Digital Omnibus; the CRA’scarve-out limits for companion apps, cloud dashboards, and update infrastructure; Data Act access rights; and NIS2/Cybersecurity Act obligations. You will leave with a clear understanding of which deadlines and requirements apply to which parts of your product, and how these frameworks interact with one another.
15.30 Closing
Sign up for the waiting list
Our event is currently fully booked, but would you like to attend? Sign up for our waiting list, and we'll contact you if a Location becomes available.
More information
Date: October 6, 2026
Location: Kista Science Tower, Färögatan
Time: 8:30 - 15:30
Fee: Free of charge
What did participants think of previous events?
"Fantastic initiative!"
"Interesting lectures."
"Good balance between lecture and mingle time."
"Well organized."
"Nice atmosphere."
"Sign me up, I'll come next time too!"
"When are you doing this again?"
questions?
Want to know more about the event or have questions? Do not hesitate to contact Jonas.
Jonas Wandell | Compliance Excellence Day Coordinator |jonas.wandell@tmp.plantvision.se | +46 761 033 571
Compliance Excellence Day 2026
On October 6, we’re once again hosting our popular Compliance Excellence Day in Kista! We warmly welcome you to a packed day of engaging presentations and networking. Sign up hereA packed program
Tune in as our experts share their insights on a range of current topics. News, trends, and other issues of great importance to the industry will be discussed throughout the day. Be sure to also take the opportunity to meet with several industry organizations that will be at Location.Throughout the day, there will be a variety of presentations for you to choose from. Whether you’re interested in “Cybersecurity from a Regulatory Perspective” or “AI in Life Sciences—Innovation and New Challenges,” we have something for you. Register today and secure your spot at Location.Some highlights
Inspiration, news, trends & networking. Sounds interesting, doesn't it? Here are some of the topics we will discuss during the day.Notified body - the road to successful CE marking
What is the CE marking process? Gain in-depth knowledge and insights from notified bodies to ensure your products meet all requirements.AI takes Location in the regulated world
Carl Adelsköld & Anders Christensen discuss artificial intelligence and the use of AI solutions, validation and regulatory requirements.Daniel Karlsson Keynote Speaker
While the media is talking about ChatGPT, AI systems are already discovering new Pharma. Daniel takes us behind the scenes as AI meets lifescience.
The Path to a Successful eQMS
Mattias Anderson talks about the benefits of an eQMS and what to consider when it comes to system selection, implementation and validation.AI Governance made easy via ISO 42001
Alex Shepherd (BSI Group). Important insights for those looking to future-proof their organizations by embedding strong AI governance practices.Notified body - the road to successful CE marking
What is the CE marking process? Gain in-depth knowledge and insights from notified bodies to ensure your products meet all requirements.AI takes Location in the regulated world
Carl Adelsköld & Anders Christensen discuss artificial intelligence and the use of AI solutions, validation and regulatory requirements.Daniel Karlsson Keynote Speaker
While the media is talking about ChatGPT, AI systems are already discovering new Pharma. Daniel takes us behind the scenes as AI meets lifescience.The Path to a Successful eQMS
Mattias Anderson talks about the benefits of an eQMS and what to consider when it comes to system selection, implementation and validation.AI Governance made easy via ISO 42001
Alex Shepherd (BSI Group). Important insights for those looking to future-proof their organizations by embedding strong AI governance practices.Meet our partners
During the day, you will also have the opportunity to meet some different organizations that we work with.Agenda
Click on the tabs below to see the lectures under each time block. On the day, simply choose which of the two lectures you want to listen to. (We reserve the right to make any changes to the agenda). Sign up here Welcome & ScheduleBlock 1Block 2Block 3Block 4Block 5Keynote08.30 Welcome!
15.30 Closing
We look forward to welcoming all participants to our Compliance Excellence Day in October. The opportunity to come together and discuss what’s happening in our industry—why it’s happening and what the future holds—is of great value to everyone who attends and takes part in this event. Through networking and open discussions, we’re confident that we’ll all go home with a few new insights and experiences.We’ll start the day at 8:30 a.m. with breakfast and mingling. Lunch and an afternoon coffee break are included, and we’ll wrap up the day at 3:30 p.m.—with the option to stick around a bit longer to continue discussions and networking. Welcome!Do I need to validate my newly purchased system for Medtech?
Room 1An overview of the steps for validation with a deep dive on assessing what needs to be validated and how extensive the validation should be. The track focuses on software applications used in Medtech.
Maria Liljevret & Lina Stange
PlantvisionThe digital thread that supports tomorrow's production
Room 2How can manufacturing companies derive greater value from their production while meeting increasing demands for quality, traceability, and sustainability? We’ll share insights on how a platform for digitalization and data can pave the way for the future of work—from smart analytics to AI.
Linn Fransson
PlantvisionEHDS – How Does It Affect the Industry?
Room 1EHDS: The European Health Data Space (EHDS) Regulation will transform how access to and use of health data in Europe are governed. For MedTech and AI developers, this presents both new opportunities to access critical datasets and new challenges regarding control and privacy. We’ll discuss how you can prepare and turn these requirements into strategic advantages.
Henrik Fält Padoan
PlantvisionThe road to an eQMS
Room 2An electronic quality management system (eQMS) helps streamline and automate document management, training, and case management in accordance with applicable regulations. In this presentation, we will discuss the benefits of such a system as well as key considerations regarding system selection, implementation, and validation.Mattias Anderson
PlantvisionMattias Anderson
PlantvisionUpcoming regulatory updates; e.g. Annex 11 & Annex22
Room 1The update to EU GMP Volume 4, Annex 11—which was decided upon in 2022 in a concept paper—has now reached the stage where the EMA has published drafts for public consultation. Much has changed from the current version of Annex 11, and the text has been divided into sections covering documentation, computerized systems, and AI. In this presentation, we will highlight the major changes and discuss how we believe the drafts may affect our day-to-day operations.Jonatan Svedmyr
PlantvisionAI Governance made easy via ISO 42001
Room 2This session is designed for business leaders, product managers, and AI developers looking to future-proof their organizations by embedding strong AI governance practices. We’ll explore how the ISO 42001 standard can be a powerful enabler—not just for compliance, but for building trustworthy, ethical, and high-impact AI systems.
Alex Shepherd
BSI GroupCybersecurity work despite unclear regulatory requirements
Room 1The NIS2 Directive is set to reshape the cybersecurity landscape in Sweden, but it is difficult to prepare when the requirements are unclear and the timelines keep changing. This, in turn, can lead management teams to become more restrictive with both investment budgets and resources. During the presentation, we’ll discuss where we stand today, what lies ahead, and how organizations can take a proactive approach to cybersecurity despite the uncertainty surrounding the regulations.
Beatrice Orback
PlantvisionAI takes Location in the regulated world
Room 2Artificial intelligence is revolutionizing large parts of the workplace, and it is also gaining ground in pharmaceutical manufacturing and Medtech . In this presentation, we’ll look at the use of AI solutions, validation, and regulatory requirements.Carl Adelsköld & Anders Christensen
PlantvisionNotified body process & the road to successful CE marking
Room 1What does the CE marking process entail? Gain in-depth knowledge and insights from Notified Bodies to ensure that your products meet all requirements.Panel discussion
Representatives from: Rise, BSI, Intertek, TÜV SÜDContract manufacturing in practice - risks, solutions and lessons learned
Room 2In this presentation, we’ll focus on contract manufacturing in the pharmaceutical industry. We’ll explain why external manufacturers are used and how to ensure regulatory compliance and high quality when production takes place outside your own organization. Using concrete examples from our operations, we’ll show what a supply chain might look like in practice and which factors are critical as the chain becomes more complex. We’ll share our experiences and insights—both regarding what is required for successful collaborations and how we’ve handled challenges, as well as the lessons we’ve learned.Avista Said
PlantvisionAnders Wallström
X-braneKeynote speaker | Daniel Karlsson, PhD
Room 1While the media is talking about ChatGPT, AI systems are already discovering new Pharma by analyzing millions of molecular structures in seconds. Daniel takes you behind the scenes of what really happens when AI meets lifescience.Daniel Karlsson is an experienced keynote speaker and AI advisor specializing in helping companies and organizations understand and implement generative AI. With a background in research, he has project managed both start-up tech companies and established life science companies, with projects ranging from social robots to IT infrastructure. The common goal is to help organizations create value from technological advances and thus maintain their competitiveness in a rapidly changing world.