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Evolving global cybersecurity regulations: Challenges and opportunities for medtech teams

Brad Ryba

March 26, 2024

4 min read

The landscape of medical device regulations continues to undergo significant changes globally. Most recently, there have been some noticeable shifts in how regulators are approaching the cybersecurity of medical devices. Recent updates from leading regulatory bodies, including the U.S. Food and Drug Administration (FDA), the European Union (EU), and the International Medical Device Regulators Forum (IMDRF), signal a united front in the drive to enhance the cybersecurity measures of medical devices.

The essence of these updates is clear: Cybersecurity is considered a fundamental aspect of medical device safety and efficacy. The FDA's proposed guidance adjustments, the EU's stringent requirements under the MDR and IVDR, and IMDRF's global harmonization efforts are reshaping the regulatory requirements for a broad range of device types. These changes underscore the importance of integrating robust cybersecurity protections from the earliest stages of device design to their operational lifespan.

With the ever-increasing incidents of security perimeter and data breaches, this transition while warranted, presents challenges for manufacturers to elevate their cybersecurity practices, to innovate with security in mind, and to navigate a complex global regulatory landscape. Yet, it also opens up opportunities to lead in the development of safer, more secure medical technologies that earn the trust of patients and healthcare providers alike.

FDA Cybersecurity Guidances

In the evolving landscape of medical device regulation, the FDA has proposed pivotal updates to its cybersecurity guidance, aiming to fortify the resilience of medical devices against cyber threats. This move reflects the growing interconnectedness of medical devices and the escalating sophistication of cyber threats targeting the healthcare sector. The FDA's draft guidance, "Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act," introduces an entirely new section dedicated to enhancing device cybersecurity throughout its lifecycle. This update emphasizes the criticality of integrating cybersecurity measures from the design phase through the entire lifespan of the device, encompassing premarket authorization, 510(k) clearances, De Novo requests, and more.

One of the significant highlights from the FDA's proposal is the emphasis on ensuring that devices capable of internet connectivity, whether intentionally or unintentionally, maintain stringent cybersecurity safeguards. This perspective stems from an understanding that the ability to connect to the internet inherently poses potential cybersecurity risks. It also expands best practices for cybersecurity within the medical device sector, building on the earlier adoption of a Secure Product Development Framework (SPDF). This framework aims to minimize vulnerabilities in medical devices by incorporating robust processes throughout the product development lifecycle. The guidance also stresses the importance of transparency, urging manufacturers to provide users with comprehensive cybersecurity controls, potential risks, and technical details through labeling. This approach is intended to empower users to manage cybersecurity risks effectively and respond promptly to any identified issues.

In addition to the FDA updates to cybersecurity guidance within medical device regulations, similar positions have been taken by other global regulatory bodies, recognizing the critical importance of cybersecurity in medical devices. As these frameworks get enacted and updated, the industry is seeing a unified drive toward enhancing the cybersecurity of medical devices, reflecting the global nature of both healthcare and cyber threats.

European Union (EU) Cybersecurity Guidelines

The European Union has continued to be proactive in addressing cybersecurity concerns through the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The MDR, which came into full application in May 2021, and the IVDR, fully applicable from May 2022, incorporate specific requirements for ensuring the cybersecurity of medical devices. These regulations require manufacturers to consider cybersecurity at all stages of a device's lifecycle, from initial conception to decommissioning.

More recently, the EU has introduced updates to the Cyber Resilience Act and drafted a new EU cybersecurity rule to establish a European cybersecurity certification scheme (“ECCS”). The ECCS would introduce a detailed certification process, prohibiting self-assessment even for low-risk products. It mandates vulnerability disclosure for certified products, sets rigorous expectations for regulators and certification bodies, including regular product sampling and peer assessments, and requires a proactive approach to vulnerability management. The ECCS also would allow for the mutual recognition of standards internationally and mandate the consolidation of existing national certification schemes. This comprehensive approach highlights the EU's commitment to enhancing cybersecurity across the board.

IMDRF Cybersecurity Guidelines

The International Medical Device Regulators Forum (IMDRF) has also published guidance aimed at harmonizing cybersecurity practices. The IMDRF's guidelines focus on principles for medical device cybersecurity, which include risk management, post-market surveillance, and information sharing amongst stakeholders. These guidelines serve as a reference point for both regulators and manufacturers, aiming to foster a unified approach to addressing cybersecurity risks.

Impact on Device Manufacturers

Manufacturers must navigate these evolving regulatory landscapes, ensuring their devices comply with each jurisdiction's specific requirements. This means incorporating robust cybersecurity measures from the design phase through the entire product lifecycle. Expectations include the ability to update and patch devices in the field, conduct thorough risk assessments, and maintain transparency about a device's cybersecurity measures. The impact of these changes means that medtech design and commercialization pipelines will need to incorporate cybersecurity as a core component, rather than an afterthought. Manufacturers should anticipate:

Increased Scrutiny: Regulatory submissions will likely require more detailed cybersecurity information, including evidence of risk assessments and mitigation strategies.

Lifecycle Management: There will be a need for plans to address cybersecurity throughout a device’s lifecycle, including mechanisms for providing updates and patches.

Global Harmonization: While regulations may vary in specifics from one region to another, the overarching principles of ensuring device safety and effectiveness through cybersecurity measures are consistent. Manufacturers looking to enter multiple markets will benefit from developing products that meet high cybersecurity standards capable of satisfying various regulatory requirements.

The Path Forward for Medtech Cybersecurity

As medical devices become increasingly interconnected and reliant on digital technologies, the importance of cybersecurity cannot be overstated. The FDA’s, European Union’s, and IMDRF’s updates are part of a broader global movement towards securing medical devices against cyber threats. Manufacturers must stay informed about these regulatory changes, integrating cybersecurity into every stage of their device’s development and lifecycle in order to properly comply with regulatory requirements.

Manufacturers and stakeholders should also closely monitor developments in cybersecurity regulations across all jurisdictions where they operate or plan to market their devices. Engaging with regulatory bodies, participating in industry forums, and adopting best practices in cybersecurity will be key strategies for navigating these evolving landscapes successfully and ensuring the trustworthiness and resilience of medical devices in the digital age.

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How Market Access Builds Trust in Regulatory Intelligence

Trustworthy AI for medtech market entry requires source traceability, regulatory specificity, and human judgment to turn regulatory intelligence into defensible business decisions.

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Rimsys Announces AI-Native Market Access for Regulated Products

New software gives regulatory and commercial leaders a source-linked, actionable view of market viability, requirements, timing, and risk before committing resources

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From Regulatory Knowledge to Better Market Decisions: A Conversation with Steve Gens and James Gianoutsos

October 1, 2026

4 min read

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AI is moving quickly from experimentation to implementation across life sciences. For regulatory teams, that raises a bigger question than where AI can automate a task:

How can organizations use AI to make better decisions while maintaining the traceability, expert oversight, and confidence regulatory work demands?

That was a central theme when James Gianoutsos, Founder and CEO of Rimsys, joined Steve Gens, Founder and Managing Partner of Gens & Associates, on the Regulatory Executive Podcast.

Their conversation explored the changing role of regulatory intelligence, the introduction of Rimsys Market Access, the importance of transparency in regulatory AI, and what these changes could mean for regulatory teams.

Regulatory knowledge has been difficult and costly to scale

For global medtech organizations, regulatory knowledge has traditionally been highly dependent on people.

A company may have specialists responsible for particular countries or regions, along with local representatives, distributors, consultants, and other experts. Those people develop deep knowledge of local regulations, pathways, and expectations.

The problem is that the knowledge often remains distributed across the organization. And maintaining that market-by-market expertise can become expensive as a company expands its portfolio and geographic footprint.

As James described during the podcast, large manufacturers may rely on dozens or even hundreds of internal employees, third-party distributors, local representatives, and other specialists to understand what it takes to bring products into different markets. Smaller organizations may rely more heavily on outside consultants and partners. Either way, the model can be costly and difficult to scale.

But the cost isn't limited to what companies spend on expertise.

Steve described the workflow as a series of “start, stop” cycles: ask a local expert, verify whether the regulation is current, gather more information, and repeat. Each cycle consumes regulatory capacity and extends the time it takes to give the business a confident answer.

That creates another potentially more consequential expense: the cost of waiting.

When it takes months to understand what entering a market will require, commercial and product teams have less visibility into when revenue might begin, what resources will be needed, or whether the opportunity is worth pursuing. Regulatory teams spend valuable capacity assembling and validating information rather than applying their expertise to more strategic work.

Ultimately, scaling regulatory knowledge isn't simply an efficiency problem. It affects how quickly and confidently the business can decide where to invest.

The bigger question: Should we enter this market?

That challenge is central to Rimsys Market Access.

Most market-entry research begins with questions such as: How is the product classified? What's the regulatory pathway? What are the requirements?

Those questions establish whether a company can enter a market. But they don't necessarily tell the business whether it should.

Market Access is designed to help regulatory and commercial teams develop an earlier view of what market entry could involve, including classification, regulatory pathway, timeline, cost considerations, requirements and potential gaps.

For commercial and product leaders, that provides greater predictability before committing budget and resources.

For regulatory leaders, it means starting with a structured plan rather than assembling every market assessment from scratch.

Moving regulatory knowledge from individuals into a shared system

During the conversation, James described one of AI's most significant opportunities as moving knowledge that has historically lived in people's heads into software.

The goal isn't to eliminate regulatory expertise. It's to make that expertise more scalable.

Market Access works from a curated regulatory corpus, allowing market-specific knowledge to be applied across workflows without requiring every initial question to go through the individual who happens to know that jurisdiction. Outputs are designed to trace back to the underlying regulation, guidance, or law.

That can also change where regulatory professionals spend their time. Rather than focusing as heavily on finding information and assembling initial assessments, they can focus on reviewing the evidence, identifying gaps, applying judgment, and advising the business.

Steve described the concept as a subject-matter-expert assistant. James called it a workforce multiplier.

Trust requires opening the regulatory AI “black box”

Speed isn't enough when the information is being used to inform regulatory decisions.

James and Steve returned repeatedly to the importance of knowing where an AI-generated answer comes from. As Steve summarized it during the discussion, transparency builds trust.

Market Access is designed around that principle. Its outputs are grounded in a curated regulatory corpus and traceable to the specific regulations, guidance, or laws supporting them. That gives regulatory professionals the ability to verify an answer rather than simply accept it.

Human judgment remains essential as well. Market Access provides an upfront assessment, not a guarantee of a regulatory outcome. Reviewer interpretation and other factors can still affect what happens during the regulatory process.

The objective isn't to make uncertainty disappear. It's to make what is known, what the sources say, and where uncertainty remains much easier to see.

Connecting the market decision to execution

The discussion also pointed to a broader evolution in regulatory technology: moving from systems that primarily store regulatory information toward systems that help teams act on it.

That's where Market Access and Rimsys RIM play distinct but complementary roles.

Market Access is the planning layer. It helps teams determine whether, when, and how to enter a market.

Rimsys RIM is the execution layer. It manages the registrations, submissions, regulatory changes, and ongoing regulatory work required to act on that plan.

Together, they create a path from the initial market decision through regulatory execution rather than leaving planning and execution disconnected.

A new role for AI in regulatory work

One of the most interesting themes from Steve and James's conversation was that AI's impact may ultimately be less about replacing individual tasks and more about expanding what regulatory teams can accomplish.

Better access to market-specific knowledge can help professionals work across more markets, spend less time gathering information, and devote more capacity to the judgment and strategic work that requires their expertise.

The technology is changing quickly, but the fundamentals of regulatory work remain: reliable information, domain expertise, transparency, and human judgment.

The opportunity is to apply those fundamentals at greater scale while giving the business a clearer answer to the question that comes before execution:

Not simply, “Can we enter this market?”

But, “Should we?”

Listen to the full conversation

Hear the complete discussion between Steve Gens, Founder and Managing Partner of Gens & Associates, and James Gianoutsos, Founder and CEO of Rimsys, on the Regulatory Executive Podcast for more on regulatory AI, market-entry planning, transparency, and the changing role of regulatory teams.

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How Market Access Builds Trust in Regulatory Intelligence

Bethaney Lentz

September 18, 2026

4 min read

Why source traceability, regulatory specificity, and human judgment matter when AI informs a market-entry decision.

Regulatory professionals are not short on AI options. General-purpose tools can answer questions quickly and often sound convincing. But in medtech, a convincing answer is not the same thing as a decision you can defend.

That distinction matters most before a company commits to a new market. Teams need to understand how a product is classified, which pathway applies, how long entry may take, what it may cost, where the important gaps are, and what uncertainty still remains. Commercial leaders need that visibility to decide whether the opportunity is worth pursuing. Regulatory leaders need to know that the assessment is grounded in sources they can verify.

That is the trust standard behind Rimsys Market Access. It is not simply about producing regulatory information faster. It is about helping medtech teams decide whether, when, and how to enter a market before committing budget and resources, with outputs linked back to the regulations, guidance, and laws behind them.

Why fluency is not enough for regulatory work

A general AI tool can be useful for brainstorming, summarizing, and exploring a topic. The challenge comes when an answer has real regulatory consequences. A plausible response may still be incomplete, based on the wrong designation, or disconnected from the current source that should govern the decision.

Medtech makes this especially difficult because the same product can be treated differently across markets and product designations. Medical device, IVD, cosmetic, consumer, OTC, and combination-product considerations can change the regulatory read. A market-entry assessment has to account for that context rather than assume one answer travels cleanly from one jurisdiction to another.

For regulatory teams, the natural next question is: Where did this answer come from? If the system cannot show the underlying authority, the expert still has to rebuild the research before trusting the result. That limits the value of the speed AI was supposed to create in the first place.

Trust starts with a decision you can verify

Market Access is designed around a different outcome. The goal is not to give teams another stream of regulatory information to interpret. It is to provide a source-linked market plan that helps them answer the bigger business question: should we enter this market, not just can we?

For a market assessment, that can include classification, regulatory pathway, timeline, cost considerations, key requirements and potential gaps. The output is designed to give commercial and product leaders an earlier, more defensible view of the opportunity while giving regulatory professionals the detail they need to review the basis for the assessment.

Trust comes from being able to inspect that basis. Market Access works from a curated regulatory corpus spanning more than 200 markets rather than relying on the open web. Answers are linked to the specific regulation, guidance, or law behind them, so a regulatory professional can verify the source instead of being asked to accept an AI-generated conclusion on faith.

Three things make regulatory intelligence more defensible

1. Source traceability

A regulatory answer is more useful when the person reviewing it can follow the evidence. Market Access links outputs back to their underlying regulatory sources. That changes the review process from “Do I trust the AI?” to a more practical question: “Does the cited source support this conclusion for our product and situation?”

That is an important shift for regulatory teams. Instead of assembling every market assessment from a blank page, they can review a structured, sourced plan, challenge assumptions, and focus their expertise on the places where judgment matters most.

2. Regulatory specificity

Trust also depends on context. Market Access is purpose-built for medtech regulatory complexity and supports cross-designation classification. The objective is to evaluate the product in the context of the market and the applicable regulatory framework, then carry that context into the pathway, requirements, timeline, cost considerations, and gaps that shape the market-entry decision.

This is where a purpose-built market-planning platform differs from a generic chat experience. The value is not an impressive answer in isolation. It is a connected assessment that helps the team understand what entering the market is likely to require and whether the opportunity still makes sense once those requirements are visible.

3. Human judgment stays in control

No system can remove every area of uncertainty from regulatory work. Reviewer interpretation and expert judgment still affect outcomes, and Market Access is not designed to promise approval.

Instead, Market Access is designed to make uncertainty more manageable. Regulatory professionals review and validate the work before it moves into execution. They can verify sources, assess the gaps, and apply company and product context that software cannot fully replace. The technology accelerates the research and planning. The regulatory professional remains responsible for the judgment.

What trust looks like in a market-entry decision

Imagine a team evaluating several markets for a new product. The commercial question is not simply whether registration is technically possible. The team needs to know which markets deserve investment now, which may require more evidence or resources, and which could put the revenue window at risk because the pathway is longer or more complex than expected.

Regulatory has a different, but connected, need. They have to understand the classification and pathway, identify the requirements most likely to slow the submission, and confirm that the plan reflects the relevant regulatory sources.

Market Access brings those views together. Commercial and product leaders get earlier visibility into timing, cost considerations, requirements, and risk so they can build a stronger business case. Regulatory teams get a source-linked plan they can review rather than a collection of unsupported conclusions. Both groups are working from the same market-entry picture before significant resources are committed.

Trust is not the end goal. Better decisions are.

It is easy for a conversation about regulatory AI to become a conversation about models, agents, or architecture. Those details matter, but they are not the business outcome.

The real value of trustworthy regulatory intelligence is what it lets a team do next. It can help a commercial leader defend a market investment. It can help regulatory surface issues earlier. It can give both groups a more predictable view of the work ahead before budget, R&D capacity, or launch timing is locked in.

And once the decision is made, the work does not have to stop at an intelligence report. Market Access is the market-planning layer. Rimsys RIM is the execution layer for registrations, submissions, regulatory changes, and ongoing regulatory work. Each can stand on its own, and together they create a path from the market-entry decision into controlled execution.

A more useful standard for regulatory AI

The question for medtech teams should not be whether AI can produce a regulatory answer. It can. The better question is whether that answer is specific enough, traceable enough, and reviewable enough to support a real decision.

Market Access is built around that standard: a defensible view of whether, when, and how to enter a market, grounded in curated regulatory sources and kept under human review. Because when the decision affects revenue, resources, and regulatory strategy, sounding right is not enough. Teams need to see why the answer is right, where uncertainty remains, and what it means for the decision in front of them.

Rimsys Announces AI-Native Market Access for Regulated Products

Bethaney Lentz

September 1, 2026

4 min read

New software gives regulatory and commercial leaders a source-linked, actionable view of market viability, requirements, timing, and risk before committing resources

PITTSBURGH, PA, September 1, 2026 - Rimsys, the heart of medtech regulatory operations, today announced Market Access, a new AI-native product designed to help companies determine whether a market is worth entering and what it will take to get there. Market Access will be available in beta beginning September 1, 2026, with general availability to be announced separately.

Market Access replaces what can be a 6-to-9-month research and assessment process with a same-day, actionable read on market viability. It gives regulatory and commercial leaders the classification, pathway, timeline, cost considerations, and potential regulatory gaps they need to make a more defensible investment decision before committing budget and resources.

Predictability is at the core of Market Access. Rather than simply identifying a regulatory pathway, it helps teams understand what to expect, which requirements or gaps are most likely to slow down a submission, and where uncertainty remains. Every answer traces back to the specific regulation, guidance, or law behind it, allowing regulatory professionals to verify the underlying source rather than simply trust an AI-generated response.

Key features and benefits include:

Same-day market assessment: Provides an actionable read on whether a market is worth entering, replacing research and assessment that can take 6 to 9 months.
Cross-designation classification: Evaluates products across medical device, IVD, cosmetic, consumer, and OTC designations, so the same product receives the appropriate regulatory read regardless of how a given market classifies it.
Clear market-entry requirements: Provides classification, regulatory pathway, timeline, cost considerations, and key requirements before teams commit resources.
Earlier visibility into regulatory gaps: Surfaces the specific requirements and gaps most likely to slow down a submission and helps teams understand their potential severity.
Greater predictability: Provides visibility into anticipated regulatory response windows, risks, and areas of uncertainty so teams can better plan for what lies ahead.
Source-linked intelligence: Traces answers to the underlying regulations, guidance, and laws so regulatory professionals can verify the basis for an assessment.
AI with human oversight: Uses Rimsys AI and Market Manager Agents to accelerate complex regulatory research while keeping regulatory professionals in control of review and validation.
Connected planning and execution: Complements RIM, connecting market-entry decisions with the registrations, submissions, regulatory changes, and ongoing compliance required to execute them.

“Regulatory knowledge has traditionally been highly dependent on individual expertise and market-by-market research,” said James Gianoutsos, Founder and CEO of Rimsys. “Market Access gives companies greater predictability before they make a market investment. Teams can understand whether an opportunity is worth pursuing, what it will take to enter, where regulatory challenges are likely to emerge, and what uncertainty remains. And because every answer is tied to its regulatory source, experts can verify the recommendation rather than simply trust the AI.”

Market Access is powered by Rimsys AI, which works from a curated regulatory corpus spanning more than 200 markets, not the open web. Its Market Manager Agents are AI agents with market-specific regulatory knowledge, including pathways, requirements, and documentation, that support market assessments and global launch planning. The product is also designed to acknowledge areas where reviewer interpretation and expert judgment can affect regulatory outcomes rather than presenting those outcomes as more predictable than they are.

Market Access expands the Rimsys product portfolio from regulatory execution into market planning. Market Access helps regulatory and commercial leaders determine where to compete, while RIM manages the registrations, submissions, regulatory changes, product data, and ongoing compliance required to enter and remain in those markets. Together, they turn regulatory intelligence into coordinated action, helping regulatory teams accomplish more in every hour while giving business leaders greater visibility into opportunities, risk, and the work required to protect and grow revenue.

Beta Availability

Market Access will be available in beta beginning September 1, 2026. During the beta period, Rimsys will continue validating product capabilities and refining workflows ahead of broader commercial availability.

Organizations interested in learning more about Market Access or participating in the beta program can visit rimsys.io/products/market-access.

About Rimsys

Rimsys is the heart of regulatory operations, connecting AI-native market planning with AI-embedded regulatory execution, giving medtech manufacturers one living system from market-entry decision to execution.

Rimsys Market Access is the planning layer, answering not just whether a market can be entered, but whether it should be, returning classification, pathway, timeline, and cost before a team commits budget or resources to finding out. Rimsys RIM is the execution layer, managing registrations, submissions, regulatory changes, and compliance so teams can act on that plan with confidence.

Trusted by 6 of the top 12 global MedTech manufacturers and certified to ISO 27001 and SOC 2, with ISO 42001 certification for AI management systems underway, Rimsys keeps regulatory intelligence, product data, approvals, and change management continuously connected so teams can enter new markets with speed and assurance. Learn more at rimsys.io.

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