Kiwa Stories - Articles

Changing your MDR EU Notified Body or ISO 13485 Certification Body can be complex, time-critical, and risky if not managed carefully. With our Seamless Transfer Program, Kiwa Assurance (NB 1912) supports medical device manufacturers in transferring with confidence—ensuring full control over timelines, certification continuity, and communication.

At our recent RAPS session in Lisbon, one message clearly emerged: under MDR (EU) 2017/745, clinical evidence is a continuous lifecycle process that depends on the strength of the entire ecosystem.

Without water, we couldn’t survive. Ensuring that drinking water is safe, through testing, inspection, and certification, has been part of Kiwa's mission from the very beginning. We spoke to Dirkjan van den Berg, Senior Expert Hygienic Aspects at Kiwa, about the new directive, Kiwa’s long history with water, and why that history matters more than ever today.

Discover how Vestas Offshore Wind Belgium implemented Vinçotte - a Kiwa company’s Digi-Tags solution to optimize and simplify the statutory inspection process across its wind farm operations.

New European regulations are raising the bar for energy management. Find out how ISO 50001 can help your organization stay compliant, reduce costs and continuously improve.

Keeping food safe along the entire supply chain is the theme of World Food Safety Day 2026: "From burden to solutions — safe food everywhere". Marked on June 7 and led jointly by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations, the theme puts a spotlight on the necessity of raising food safety standards across the world.

HortaPronta is a Portuguese horticultural producer that has maintained a close partnership with Kiwa for over 20 years, following a shared journey focused on food safety certification, continuous process improvement and compliance with the requirements of both national and international markets.

In recent years, the battery industry has been moving through a period of rapid transformation. Increasing demand for electric vehicles, energy storage and light transport has not only driven innovation, but also pushed sustainability, transparency and responsible sourcing to the forefront of regulatory expectations. Against this backdrop, the European Union introduced the Battery Regulation (EU 2023/1542): a comprehensive framework designed to ensure that every battery placed on the EU market contributes to a more transparent and circular economy.

The global race towards carbon neutrality is accelerating the deployment of offshore renewable energy. Among the most promising technologies, floating offshore wind stands out as the key to unlocking deep‑water wind resources and enabling large‑scale clean energy production. Portugal is playing a pivotal role in this transition — with Kiwa Portugal recognised as a leading technical partner in this emerging market.

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.

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 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.

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.

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.

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.

On 16 March 2026, the European Commission hosted the High-Level Conference on Medical Devices: Innovation and Patient Safety in Brussels, an event that brought together key institutional representatives, regulatory authorities, industry experts, and stakeholders from across Europe.