In the competitive and highly regulated world of medical technology, a robust and well-structured Design and Development (D&D) process is not just a best practice—it is a business-critical necessity. From concept to commercialization, a robust D&D process lays the foundation for safety, compliance, efficiency, and innovation. Below, we explore why medical device companies must prioritize the stability and maturity of their development process.

Ensuring Regulatory Compliance
Medic e subject to stringent regulations such as the FDA’s 21 CFR Part 820, the EU Medical Device Regulation (MDR), and ISO 13485. A structured D&D process ensures that:
  • All design inputs are clearly defined and traceable.
  • Design verification and validation are conducted properly.
  • Risk management is integrated throughout the product lifecycle.
  • Design History Files (DHF) and technical documentation are complete and inspection ready.
Reducing Risk and Enhancing Patient Safety
A robust D&D process systematically identifies potential hazards and mitigates them early in the design phase. This is essential in the medtech sector, where device performance directly impacts patient outcomes. Risk management tools such as FMEA, fault tree analysis, and usability testing are most effective when embedded in a consistent and repeatable process.
Accelerating Time to Market
While a structured process might seem time-consuming upfront, it significantly reduces delays and rework later in development. Clear stage-gate reviews, defined deliverables, and robust design controls minimize costly surprises and speed up product launches. This is especially critical in competitive markets where speed can be a key differentiator.
Improving Cross-Functional Collaboration
Product development in medtech involves multiple disciplines: R&D, quality, regulatory, clinical, marketing, and manufacturing. A robust D&D process provides a common framework for communication and collaboration, ensuring that all stakeholders are aligned and informed. This reduces silos, improves decision-making, and enhances overall project outcomes.
Supporting Scalability and Growth
As medtech companies expand their portfolios or enter new markets, the D&D process provides the foundation for scaling operations. It ensures that quality is maintained across multiple projects, locations, and teams. Furthermore, standardized processes make it easier to onboard new talent and collaborate with external partners.
Driving Innovation with Discipline
Innovation is essential in medtech, but without structure, it can lead to noncompliance. The D&D process balances creativity with control, providing teams with the tools and freedom to innovate—while ensuring that new ideas are tested, documented, and safely implemented.
Conclusion
In an industry where patients’ lives are at stake and regulatory scrutiny is high, a robust and compliant Design and Development process is not optional—it is fundamental. Medical device companies that invest in building and maintaining mature development processes are better positioned to deliver safe, effective, and innovative products to market—quickly and sustainably.
Regardless of whether you’re a startup company or established player, a solid D&D foundation will drive long-term success.
Moreover, whether you’re developing a new process from the ground up or looking to strengthen an existing one, we can support you. Sometimes, a second opinion or external perspective can bring valuable insights, uncover hidden risks, and accelerate progress.
Contact us to learn how we can support you in building a robust, compliant, and future-proof D&D process tailored to your organization’s needs.

 

Tough times require sharp strategies – and the right expertise

The industry’s financing climate has slowed down considerably. Investments in the development of pharmaceuticals and medtech are more cautious, and Ulrika Hammarström, Head of CRO at Aurevia, emphasizes that the requirements for a clear market and regulatory strategy have never been higher. For pharmaceutical, biotech and medical device companies that want to reach the market and remain there, she underscores that expert support is no longer an option, but a must.

As Anna-Karin Alm, Head of Quality Assurance and Regulatory Affairs (QARA) at Aurevia puts it: “Medical device companies operate in an extremely challenging environment right now, both in terms of requirements for product development but also in terms of business strategy. Conditions are constantly changing – today faster than ever. Given the global uncertainty, especially related to trade policy, it is crucial to understand how to create – and maintain – success in your business. We guide companies all the way, from early development to market entry and beyond. It is not enough to just get a product approved; It’s about achieving success in the market by anticipating changes that may affect the product’s lifecycle and staying up to date on regulatory requirements.”

Read the full article in Swedish at Dagens Industri.

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.