Kiwa Stories - Articles

ISO 10993: A strategic approach to the biological evaluation of medical devices

Biological evaluation is a fundamental element in demonstrating the safety of medical devices and compliance with Regulation (EU) 2017/745 (MDR). The ISO 10993 series represents the internationally recognized standard for assessing the biocompatibility of materials and devices throughout their entire lifecycle.

Medical devices

The four-eyes principle: a foundation for trust and technical integrity

At Kiwa Medical, the four eyes principle is more than a procedural requirement—it is a daily safeguard for technical quality and regulatory confidence. Whether applied to peer reviews of audit reports, technical documentation assessments, or certification decisions, involving a second qualified reviewer before finalization adds real and measurable value.

Volume calibration of storage tanks using 3D scanning - an accredited and highly accurate method

Volume calibration of storage tanks is a vital part of safe process‑industry operations and ensures the reliability of trading liquid products sold by volume. Accurate volume data is essential for the storage, handling and sale of chemicals, fuels and other industrial liquids, as well as for process control and fulfilling regulatory requirements.

Kiwa become Auditing Organization under the Medical Device Single Audit Program (MDSAP).

This is an important step in Kiwa’s continued development of services for the medical device sector. Applicant status means Kiwa has entered the formal process toward recognition as an MDSAP Auditing Organization.

MDR Annex XVI products and Common Specifications (CS)

Annex XVI of EU MDR 2017/745 covers specific product groups that do not have a medical intended purpose, yet are used on the human body and inherently carry certain risks. Although these products are not intended for diagnosis or treatment, they are included within the MDR framework due to their potential impact on human health and safety.

Kiwa joins RAPS Europe 2026

From 5 to 8 May 2026, Lisbon will host a new edition of RAPS Europe, one of the leading European events dedicated to Regulatory Affairs in the life sciences and medical devices sector.

RAPS Europe 2026 in Lisbon

CBTL scope extension Electrical safety testing

We are proud to announce that Kiwa Nederland has extended their CBTL accreditation with electrical safety testing of medical devices. This milestone allows us to support medical device manufacturers even more effectively in demonstrating compliance with international standards, not only for EMC, but now also for electrical safety. 

Close-up of a sprinkler head mounted.

World Earth Day 2026

As a testing, inspection, and certification company, our sustainability sector is all about harnessing ‘Our Power’ to make a difference. Our work helps businesses around the world adapt to shifting regulations, measure their environmental performance, and build the transparent practices that stakeholders increasingly demand and that our planet needs.  In this article, Justin shares more about Kiwa's sustainability solutions and what they mean for businesses working toward a greener future.

From onetime checks to continuous confidence: evolving Supplier Assurance

In today’s food, feed and agriculture supply chains, risks don’t wait for an annual audit cycle. New materials, changing processes, staff turnover, regulation updates and market pressures can influence performance at any time.  That’s why forwardthinking organizations are moving toward a more dynamic model of supplier oversight, one that blends structured audits with continuous insight and proactive collaboration. 

Reliable 5G Device Testing: Ensuring Compliance, Performance and Market Access

The introduction of 5G marks a significant development in wireless communication, bringing new technical requirements and performance expectations for modern radio equipment. For manufacturers and integrators developing 5G-enabled products, reliable testing and validation are essential. With deep expertise in radio-frequency engineering and modern laboratory facilities, Kiwa helps organizations verify that their 5G devices meet international standards and function reliably across all intended use cases.

Safety from the inside out this World Day for Safety and Health at Work

This year's theme, "Let's ensure a healthy psychosocial working environment," centers on the health and wellbeing of workers, and the way everyday working conditions are designed, managed, and organized. In this article, our Global Head of Health & Safety, Ellen de Geest, shares how at Kiwa safety starts within our own walls, and how our services help strengthen safety standards across the world.

Moving dam inspections from the field to the desktop

Inspecting the interior of concrete dams is often hindered by poor lighting and restricted access, making it difficult to get a comprehensive overview of the structural condition. By building an ultra-high-resolution 3D model of the galleries at the Storfinnforsen dam, we have demonstrated how visual inspections can be entirely transitioned to a digital desktop environment. The result is an impressive level of detail, allowing for the detection and exact geospatial anchoring of all defects, such as cracks as fine as 0.2 millimeters.

A practical view on MDR and its challenges

Since the introduction of MDR (EU) 2017/745, many manufacturers describe the regulation as demanding and time-intensive. And while MDR is thorough by design, many of the hurdles companies face stem from fragmented processes rather than the regulation itself.

A Day in the Life of a Carbon and Sustainability Services Director, Stephen Burt

Step inside a day in the life of Stephen Burt, Carbon and Sustainability Services Director at NQA, a Kiwa company. From early-morning travel on the Caledonian Sleeper to on-site audits of major infrastructure projects, discover how carbon verification, stakeholder collaboration, and whole life carbon assessments come together in practice. This behind-the-scenes look highlights the real-world work driving more sustainable outcomes across complex projects.

Celebrating World Water Day 2026

"Today reminds us that inequalities in access to safe water affect people in different ways, and that water equity extends beyond any single dimension", say Business Unit Managers Jessica Weigert and Annemieke van der Velden.  "For us, leading Kiwa’s Water Business in Germany and the Netherlands, diversity is not an abstract value but a lived reality: our teams bring together people from different cultures, backgrounds and personal experiences, including colleagues who know from their own lives what it means not to have reliable access to water."

Kiwa attends the GFSI Conference 2026

Kiwa will attend the GFSI Conference 2026, taking place from 24 to 26 March 2026 in Vancouver, Canada. The conference brings together food industry leaders, retailers, manufacturers, certification bodies and regulators from around the world to collaborate on strengthening food safety and trust across the global supply chain.

From Uncertainty to Clarity: The Impact of Structured Dialogue in MDR Assessments

In the last year, structured dialogue has become an essential tool in collaboration between manufacturers and Notified Bodies under the MDR. New requirements, stricter deadlines enforced a need for more and structural communication.

A Fresh Perspective on Supplier Audits: Stronger Together

Many organizations choose to perform their own supplier audits — and they do so with impressive dedication, deep product knowledge, and a genuine commitment to quality. Yet within that approach lies an interesting opportunity. Not to replace what already works, but to strengthen it.

Kiwa builds a new test hall for CE certification of sprinklers

Kiwa is expanding its fire safety and security services! In Zaltbommel (the Netherlands) the construction of a brand-new test hall is in development, specifically for testing and certifying sprinklers according to EN 12259-1. With this expansion, we will soon be able to test sprinklers so that they can be provided with a CE-marking.