How NorrDia Uses Standards to Ensure Compliance and Patient Safety Worldwide
Last updated:
April 8, 2026
In the world of medical technology, reliability is essential. For NorrDia Belgium, an Organisation provides CRRT therapies for patients with acute kidney failure in intensive care, standards are not a mere formality, but a cornerstone.
“Standards are absolutely essential to us,” says Marcelle Liebert, Regulatory Affairs Associate at NorrDia Belgium. “They provide a structured framework to ensure that our products are safe and effective, and comply with all regulations.”
Together with her colleagues, she ensures that NorrDia’s products can be—and remain—marketed worldwide.
NorrDia Belgium operates in an industry where compliance is crucial. Medical devices and pharmaceutical products must meet strict requirements before they can be brought to market.
“We operate in a highly regulated environment,” says Veerle Leijnen. “If you want to bring products to market, you have to be able to demonstrate that everything meets the requirements—from your quality system to your technical documentation.”
One of the most important standards in this regard is ISO 13485, which forms the basis for the quality management system.
In addition, NorrDia adheres to a wide range of standards covering areas such as risk management, biocompatibility, and sterilization. “We use a lot of them,” says Marcelle, “and we have to stay on top of any updates.”
Standards also play an important role in international market access. In many countries, companies must demonstrate which standards they apply.
“In many countries, we have to provide a list of the standards we follow,” says Marcelle. “If you can demonstrate that you operate in accordance with recognized standards, that’s sufficient for most countries.”
Standards thus ensure a more efficient and streamlined process for bringing products to market internationally.
Regulations are becoming increasingly complex worldwide. More countries are introducing stricter requirements, and regulatory filings are becoming more extensive.
“The requirements are becoming stricter and more extensive,” says Veerle. “The documentation we need to submit to bring products to market is growing all the time.”
This puts additional pressure on teams, which must comply not only with standards but also with guidelines, regulations, and other references.
Although this creates extra work, the goal is clear.
“At the end of the day, you want to prove that your product is safe, effective, and does what it’s supposed to do,” says Marcelle.
Or as she puts it herself: “We’re not selling candy.”
Standards are therefore not just unnecessary paperwork, but essential for patient safety.
CE marking is mandatory for medical devices in Europe, but it is not a simple formality.
For each product, NorrDia must prepare a technical dossier containing test results, validations, and risk analyses. A notified body then assesses whether everything meets the requirements.
Only then is the certificate issued—as proof that the product meets European safety and performance requirements.
Over the years, the number of standards has grown significantly. In the past, compliance was managed entirely manually.
“That list just kept getting longer,” says Veerle. “It simply became too time-consuming to keep track of everything myself.”
Today, NorrDia uses the NBN Standards Portal to centralize this process.
In a highly regulated industry, operating under outdated standards can lead to compliance risks.
Online standards management ensures that teams always have access to the latest versions and can therefore continue to work accurately.
The portal is used by various teams, including Regulatory Affairs, Quality Assurance, R&D, and Vigilance.
“It’s very simple and gives us quick access to the standards we need,” says Marcelle.
In addition, centralization reduces manual work and increases oversight.
“We know we’re working with reliable information,” she adds.
Another advantage is that they are available in multiple languages: the standards are available in English, French, and German.
Our collaboration with NBN is considered to be highly professional.
They offer a reliable platform and fast support, which is essential in a regulated environment.
For NorrDia, standards are an essential part of its operations. They enable compliance, support international growth, and ultimately ensure what matters most: patient safety.
Would you like to learn how NBN organisation help your organisation with smart standards management?
