At Kiwa Assurance, we recognize that innovation is a constant in the medical device industry. But change comes with responsibility—especially when it comes to maintaining compliance under the MDR and ISO 13485. That’s where our Notification of Change (NoC) process plays a vital role.
Any medical device that makes use of software, or is a software in itself (MDSW), could potentially fall under the Regulation 2024/1689 (informally known as ‘AI act’), if the software, or part of it, meets the definition as laid down in this Regulation*. For devices falling under the AI Act, the deadline of August 2, 2027, is fast approaching, considering the timelines for conformity assessment.
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.
Food safety is a non-negotiable priority for Astra Sweets, a confectionery producer with sites in Belgium and the Netherlands. For over a decade, the firm has been relying on our colleagues at Vinçotte Belgium, part of the Kiwa Group, to maintain the highest food safety standards – ensuring compliance as well as reaping tangible business benefits.
