ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International Standard (FDIS) was published earlier this spring, and the voting was closed the July 17. The standard was approved and is now under publication.

What’s changing?

The new version of ISO 10993-1 strengthens the alignment between biological evaluation and risk management principles.

Key changes include:

  • Closer integration with the risk management process as defined in ISO 14971. The biological evaluation is now more explicitly linked to the stages of the risk management process.
  • A revised method for calculating total exposure, focusing on the number of days from first to last exposure, rather than total contact time.
  • The table in former Annex A covering biological endpoints is replaced by several smaller tables integrated into the main text. The term biological endpoint is replaced by the term biological effect. The tables list which effects to consider for different types of device contact (intact skin, mucosal membranes, internal tissues, circulating blood). Notably, material-mediated pyrogenicity is no longer listed as a biological effect in any of these tables.
  • New requirements for the Biological Evaluation Plan, which should include or reference criteria for the acceptability of specific biological risks associated with the medical device.
  • A new annex with guidance on characterization

What does this mean for you as a manufacturer?

Manufacturers will be expected to apply the new version whenever a biological evaluation needs to be updated (for example, due to changes in the device design, materials, or manufacturing process).

To prepare, we recommend performing a gap analysis of your current biological evaluations against the new standard. In particular, consider the following:

  • Does the revised method for calculating total exposure change which biological effects you need to evaluate? If so, plan ahead to ensure future compliance.
  • Do your SOPs and templates for biological evaluation need to be updated? If yes, take steps to align them with the new requirements.

How we can support you

At Aurevia (formerly QAdvis), we closely monitor regulatory developments and help our clients stay ahead of changes. We offer:

  • Gap analyses and documentation reviews
  • Support in updating biological evaluations

Want to know more?

Feel free to reach out if you’d like to discuss how the upcoming version of ISO 10993-1 may affect your products and documentation. We’re here to help you stay compliant, informed, and ready.

 

Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Under the EU MDR, a structured, proactive approach with strong links to risk management and authority dialogue is essential.

PMS has become a cornerstone of regulatory work under EU MDR 2017/745 and IVDR 2017/746. It’s not just about responding to incidents – it involves systematically and continuously collecting, analyzing, and acting on real-world data from medical device use, both from one’s own products and from competitors. The goal is to detect hidden risks, prevent recurring issues, and strengthen patient safety.

In my work with PMS and vigilance – both as a regulatory assessor at the Swedish Medical Products Agency (Läkemedelsverket) and as a consultant – I’ve seen how often PMS is mistaken for simple complaint handling. That’s a dangerous oversimplification. True PMS is integrated into the quality management system and requires collaboration with distributors, importers, and authorized representatives. Deficiencies in documentation, traceability, or training can lead to serious consequences, including recalls or regulatory intervention and, in the worst case, severe patient harm.

Five Common Pitfalls in PMS – and How to Avoid Them

  1. Insufficient documentation and traceability:
    Missed safety signals can be costly. Establish clear processes for collecting, recording, and analyzing data.
  2. Passive data collection:
    Don’t wait for incidents to arise. Be proactive – use (e.g. real-world information from healthcare professionals using the device), PMCF/PMPF studies, and market feedback.
  3. Neglecting old products:
    Older products may develop new issues over time. Continue monitoring even years after market entry.
  4. Lack of clear event investigation procedures:
    When something happens – gather all relevant information, including the affected product, determine the root cause, update the risk analysis, and implement CAPAs.
  5. Poor communication and training:
    Your representatives, distributors, and resellers need the right knowledge to identify and report incidents in time.

Success Requires a Structured PMS Process:

  • A clear plan for data collection, analysis, and reporting.
  • Continuous monitoring of all products – including those already in use.
  • Engagement in regulatory dialogues with authorities and notified bodies for quicker risk mitigation and transparency.
  • Alignment with guidance documents such as MDCG 2023-3.
  • Sufficient resources – with the option .

Final Note
PMS reflects an organization’s approach to quality. It’s about viewing issues as opportunities for learning and improvement – not as failures. An active and effective PMS system is not just a regulatory requirement; it’s essential to protect both patients and your company’s future.

Contact us to learn how we can support you with PMS strategy, documentation, training, and regulatory guidance – so you can focus on what matters most: safety.

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.