Navigating the regulatory landscape of the medical device sector is a complex task, requiring both strategic foresight and a deep understanding of evolving global requirements. Companies must not only ensure compliance with current regulations but also anticipate changes that could impact product development, market access, and post-market obligations.

Within this context, two distinct but closely connected disciplines have emerged: regulatory strategy and regulatory intelligence. While they often overlap in practice, their roles, objectives, and deliverables are fundamentally different.

Intelligence informs Strategy and strategy sets the questions for Intelligence to answer.

a. Regulatory Strategy

  • Long-term planning aligned with business goals
  • Product lifecycle management: from development to market entry and beyond
  • Tailoring submissions based on market requirements (e.g., EU MDR vs. FDA)
  • Involves cross-functional collaboration

b. Regulatory Intelligence

  • Systematic collection, analysis, and interpretation of regulatory information
  • Monitoring changes in laws, guidance, competitor activity
  • Supporting risk assessments and early warning for strategic decisions
  • Tools: databases, newsletters, agency updates, conferences

Key Differences

Aspect Regulatory Strategy Regulatory Intelligence
Question What’s the plan to get (and stay) approved? What’s changing, and how do we adapt?
Definition A tailored roadmap that outlines how a medical device company shall navigate regulatory requirements throughout the product lifecycle—from development to market approval and post-market compliance. Continuous and ongoing monitoring, analysis, and interpretation of global regulatory developments, trends, and expectations that may impact a company’s products or strategies.
Goal To reduce time to market, avoid costly delays, and ensure compliance without overburdening development To stay proactive, informed, and competitive—avoiding surprises that could delay market access or trigger non-compliance
Focus Forward-looking plan for compliance and market access Real-time data gathering and interpretation
Output Regulatory roadmap, submission plans, labeling strategies Alerts, summaries, insights, trend reports
Nature Proactive and directional Reactive and analytical
Role Decision-making and direction-setting Information support and validation

In an increasingly dynamic regulatory environment, success depends not only on having a well-defined strategy but also on continuously feeding it with high-quality intelligence.

We help bridge the gap between intelligence and strategy. We monitor and interpret global regulatory developments, assess their impact on your specific products and markets, and translate that insight into actionable strategies. Whether you’re planning market entry, navigating complex submissions, or adapting to regulatory changes, we provide the tailored expertise needed to stay compliant—and stay ahead.

QAdvis is now Aurevia – expanding our capabilities together

We are happy to announce that QAdvis is now officially part of Aurevia. This change of name follows our company’s integration into Aurevia. The Aurevia brand was born in January, when Labquality, Artimed, Clinical Consulting, Kasve, and Prisma CRO merged under the same name. With QAdvis now proudly joining the team, we are further strengthening our expertise and services and together offering greater value to our joint customers. Scandinavian CRO is also joining Aurevia.

For years, QAdvis has been a trusted partner for companies navigating the regulatory landscape of medical devices and in vitro diagnostics. With extensive expertise and dedication to practical solutions, QAdvis has supported the industry in bringing safe, effective medical devices to market while ensuring compliance in a complex environment.

This legacy of excellence, customer focus, and dedication to quality continues as QAdvis becomes Aurevia, building on strong foundation while embracing new opportunities as part of a larger, united team across 4 European countries serving customers in over 60 countries.

“- Together, we connect our clients with our familiar, valued experts, supporting clients in enhancing their product development and quality management . Our team offers a growing skill set, not only within our core regulatory affairs and quality assurance business area, but also through collaboration with colleagues in Aurevia’s CRO business,” says Anna-Karin Alm, Head of QARA at Aurevia and formerly CEO of QAdvis.

Practical implications of change
For QAdvis clients and stakeholders, the name change will not impact ongoing projects — you will continue working with the same experts you know and trust. All contracts, NDAs, and bank details remain unchanged, while the offering to our clients is now supported by the expanded capabilities of Aurevia’s full-service team. QAdvis EAR and UKRP services and activities in the European Union and the UK remain unchanged.

What is Aurevia?
QAdvis further strengthens Aurevia’s regulatory affairs and quality assurance services and capabilities. Together, we provide QARA expertise covering the entire lifecycle of medical devices and in vitro diagnostics, from early development to post-market phases globally. Additionally, Aurevia operates as a full-service contract research organization (CRO) supporting pharmaceuticals, medical devices, and in vitro diagnostics, and EQA services ensure clinical laboratories meet required quality standards.

To learn more about Aurevia and our expanded offering, visit aurevia.com — and please note our new email addresses: firstname.lastname@aurevia.com.

We look forward to continuing our work together under our new name — Aurevia — with even more expertise, innovation, and practical solutions.

According to MDR 2017/745 “Devices shall be designed and manufactured in such a way as to ensure that their characteristics and performance during their intended use are not adversely affected during transport and storage…”  This implies the need for transport validation, meaning that you must demonstrate that the device quality is not compromised during shipping or storage — especially for temperature-sensitive, fragile, or sterile devices. You need to ensure that products maintain their safety, integrity and performance from the moment they leave the manufacturer until they reach the end user.

Transport validation is the process to demonstrate that your medical devices can withstand the conditions they will be exposed to during transportation, such as varying temperature, humidity, shock, and vibration—without being compromised. The process typically involves simulating real-world shipping conditions (e.g., drop tests, vibration tests, temperature cycling) and monitoring the actual shipments with data loggers.

Activities for how to perform transport validation:

  • Define product scope
  • Identify shipping method, routes, environmental conditions, consider worst-case-scenario
  • Perform a risk assessment to identify potential hazards and sensitivities
  • Develop a test plan, including criteria for approval
  • Conduct simulated testing and/or real-world shipment validation
  • Evaluation of the result
  • Summarize the validation report,
  • Re-validate any identified nonconformities

Ensuring adequacy in packaging for all logistical scenarios is important to ensure patient safety as damaged or degraded devices can pose serious risks during use of the medical device, and also to ensure regulatory compliance and reduce the risk of product loss, recalls, or reputational damage.

Key takeaways:

  • Integrate transport validation into your design and development process early.
  • Tailor the validation to product type, fragility, and risk class.
  • Periodically revalidate if shipping methods, packaging, or routes change.
  • Document everything in line with your QMS and regulatory requirements.
  • Transport validation isn’t just about ticking boxes—it’s about ensuring that devices arrive safely, ready to do their job where it matters most.

Contact us if you have any questions.

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For nearly 30 years, the U.S. Food and Drug Administration has played a pivotal role in shaping the global medical device industry through strict regulatory requirements, international cooperation, and adaptation to technological advancements. However, with significant changes on the horizon in the U.S., how will these developments affect medical device manufacturers in Europe?

The United States remains a crucial market for European medical device manufacturers. As the world’s largest medical device market, it offers significant opportunities for European companies seeking global expansion. Additionally, the complexity of the EU Medical Device Regulation has prompted some non-European manufacturers to prioritize the U.S. as their preferred market for growth.

In recent years, the FDA has made substantial investments to enhance regulatory efficiency and accelerate market access. Programs such as E-Star, the Breakthrough Devices Program, and the Total Product Life Cycle (TPLC) Advisory Program facilitate early engagement and prioritized review for innovative technologies. Furthermore, increased staffing and funding through the Medical Device User Fee Amendments (MDUFA) have strengthened the FDA’s review processes, ensuring a more efficient and timely approval pathway.

As of February 2025, President Donald Trump’s administration has proposed significant reforms to the FDA. The nomination of Robert F. Kennedy Jr. as Secretary of Health and Human Services (HHS) signals a potential shift in the agency’s regulatory approach and priorities. Additionally, the administration is considering an executive order that could significantly reduce the FDA’s workforce. The administration has also indicated plans to streamline FDA ´s regulatory processes to accelerate the approval of innovative medical devices. Proposed measures include reducing bureaucratic obstacles. Specific details on the implementation of these changes have, however, not yet been fully outlined.

The current uncertainties surrounding potential FDA regulatory changes under the Trump administration create challenges for EU medical device manufacturers seeking U.S. market entry. A faster, less stringent approval process could lower barriers to entry, but shifting FDA policies may create unpredictability in compliance expectations, making it harder for EU manufacturers to align their regulatory processes. This regulatory uncertainty can affect investment decisions and long-term planning for companies looking to expand into the U.S. market.

The future development of the regulatory landscape in the U.S. remains uncertain and needs to be closely monitored by manufacturers intending to enter U.S.  At QAdvis, our Quality and Regulatory consultancy team tracks these developments to support our customers and provide a proactive approach to upcoming changes. Or, to paraphrase Charles Darwin; The one most responsive to change is the one most likely to survive.

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