What you should know about our quality system and certification process

As a medical device manufacturer, choosing the right Notified Body is a critical strategic decision. You need a partner that not only understands the regulatory landscape but also operates with the highest standards of quality. It's not just about ticking boxes, it's the bedrock of trust we build with you, the medical device manufacturer, ensuring that when we give a medical device the thumbs up, it's genuinely safe and performs as it should.

The Quality Management System (QMS) is the heart of our organization. It's the set of documented procedures and practices that guide everything we do, from the moment you submit your application right through to ongoing surveillance of your certified devices. Our QMS is built upon the solid foundations laid out in EU Medical Devices Regulation (MDR) 2017/745 and the international standard ISO/IEC 17021-1. These aren't just suggestions; they are requirements we must meet to maintain our designation as a Notified Body and accreditation as Certification Body and, like you, we are also audited regularly by various external parties.

What makes our QMS so powerful?

Built on solid foundations
Our system is based on the requirements of EU MDR 2017/745 and ISO/IEC 17021-1, ensuring that we meet the highest international standards for impartiality, competence, and transparency.

Clear roles and responsibilities         
All Kiwa staff understand their duties. Whether it’s a technical expert reviewing your device or an auditor assessing your production process, responsibilities are clearly defined, and accountability is built in.

Independence and impartiality
We act as an independent referee. Our decisions are never influenced by commercial interests. We have strict procedures to manage conflicts of interest, and our staff commit to impartiality through formal declarations.

Expertise you can trust
Our team includes engineers, scientists, and clinicians with deep knowledge of the technologies and clinical applications they assess. We continuously train and evaluate our personnel to ensure they stay at the forefront of regulatory and scientific developments.

Documented and transparent processes
Every step of the conformity assessment process is guided by documented procedures. From application handling to certification decisions and surveillance. This ensures consistency, clarity, and reliability for both our assessors and our clients.

Confidentiality and care
We understand the sensitivity of the information you share with us. That’s why we have strict confidentiality protocols and secure systems in place to protect your data.

Top-down commitment to quality
Our leadership doesn’t just endorse the QMS, but they actively drive it. They set quality objectives, allocate resources, and continuously review and improve our system to ensure it remains effective and future-proof.

Global alignment
By adhering to ISO/IEC 17021-1, we align with globally recognized best practices. In addition, we are a member of Team-NB. This means our certification processes are not only robust but also internationally respected.

Partnering for quality

Just as our QMS is essential, so is yours. When your system meets the requirements of ISO 13485, it creates a strong foundation for certification and streamlines the conformity assessment process. Think of it as two well-oiled machines working in sync, driven by a shared commitment to quality and patient safety.
 

At Kiwa Assurance B.V., our QMS is more than a regulatory requirement. It’s our promise to you - and to the patients who rely on your devices - that every certification decision is made with integrity, expertise, and care.
 

Medical Devices

Medical devices manufactured or traded in the EU must comply with EU legislation in safety and health. This means they must be conformed to the pertaining product directives and regulations and must be CE marked.
Certification

CE Marking of Medical Devices in accordance with MDR

Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and more. These devices, designed for medical purposes and intended for use in or on humans, achieve their primary effects through mechanisms other than pharmacological, immunological, or metabolic actions. Before entering the European Economic Area (EEA) market, the medical devices need to be compliant to applicable legislation and obtain the CE marking.

Contact us

Would you like to know more about our services in the field of Medical devices? Please contact us using this form.