Our Commitment to Safer Diagnoses on World Patient Safety Day

On 17 September 2024, we will join the global recognition of World Patient Safety Day, an essential moment to reflect on the importance of safety within healthcare systems worldwide. This year’s theme, ‘Improving Diagnosis for Patient Safety,’ aligns closely with our mission at Kiwa — to contribute to the transparency of the quality, safety, and sustainability of products, services and organizations and personal and environmental performance.

We understand that diagnostic devices are crucial in modern healthcare. From imaging technologies like MRIs, X-rays, and CT scanners to electrodiagnostic devices and wearable health sensors, these tools are essential for detecting diseases, monitoring patients, and guiding treatment plans. Therefore, ensuring the safety and accuracy of these devices is vital, and this is where our work begins.

Supporting accurate diagnosis through certification

“As a testing, inspection, and certification service provider, we ensure that medical devices — especially those used for diagnostics — meet the highest safety and performance standards,” explains Yeşim Sekizelma, Lead Auditor and Medical Device Technical Expert at Kiwa Turkey.

“This contributes to improving patient outcomes and maintaining trust in healthcare.”

“Ensuring that these devices meet stringent safety and performance standards helps improve the reliability of diagnoses. More specifically, we certify diagnostic devices to comply with EU Medical Device Regulations (MDR 2017/745). By doing so, we verify that these devices perform effectively and meet the required legal standards for safety.”

Our role as a Notified Body

Kiwa also plays a key role as a Notified Body in Europe, certifying medical devices across various categories to meet EU safety and performance standards, enabling their legal sale within the European Economic Area.

Notified Bodies specifically handle critical stages of the CE certification process — CE marking is a well-known symbol on a range of products. It’s a vital certification that shows a product’s compliance with European safety, health, and environmental protection standards. As a Notified Body, we ensure conformity assessments and audits. We ensure devices meet stringent safety standards through technical reviews, risk management, and clinical evaluation assessments.

Furthermore, we perform these activities through three Notified Bodies: Kiwa Cermet Italia (NB 0476), Kiwa Belgelendirme Hizmetleri (NB 1984), and Kiwa Dare Services (NB 1912), ensuring compliance with European regulations for healthcare use.

How CE Marking enhances patient safety

“The CE certification is not just a regulatory requirement but an important stamp of approval and guarantee of safety and performance for medical devices,” explains Yeşim. “Diagnostic devices, such as imaging equipment, electrodiagnostic devices, and AI-based decision-making tools, require CE marking before being legally sold in Europe. CE marking ensures that the above-mentioned diagnostic devices are produced safely and by legal regulations and standards by auditing steps like risk management, quality management systems, and post-market surveillance.”

Staying current with technology and regulations

It is fundamental to stay current with regulations and technology as far as medical devices are concerned. Technological advancements including AI, biotechnology, miniaturisation, improved sensors, IoT integration, and regulatory changes, rapidly drive innovation in diagnostics, treatment, and patient care.

As such, we prioritize continuous learning and regularly monitor updates from regulatory bodies like the The European Medicines Agency (EMA) and the European Commission (EC) to ensure our certification processes meet the latest standards.

“We also invest in training for our auditors and technical experts,” says Yeşim, “keeping them informed on the newest medical device regulations and innovations. This approach helps us remain a trusted partner for manufacturers, guiding them in bringing safe, advanced diagnostic devices to market.”

Collaborating with manufacturers for safer devices

In addition to keeping up with regulations and technological advancements, we understand the challenges manufacturers face in creating effective, compliant diagnostic devices. That's why we work closely with them throughout the certification process, providing clarity on MDR and standards like IEC 60601-1 for medical electrical equipment. We evaluate manufacturers' quality management systems (QMS) to meet standards suh as ISO 13485, conduct risk management reviews, and perform ongoing audits to maintain compliance, enhancing diagnostic accuracy and patient safety.

“For the manufacturer to perform correct imaging or monitoring, they must first verify their product,” details Yeşim. “The framework that creates the design is the product standards and legal regulations. Therefore, it must be verified that the device is designed in accordance with the regulations and harmonized standards. This collaboration with manufacturers ensures that every diagnostic device is safe, effective, and built to last, from initial design to post-market surveillance.”

Towards greater patient safety

“We are proud of our role in improving patient safety,” Yeşim emphasizes. “By proactively addressing regulatory compliance and conformity assessments, we enhance our effectiveness in certification. Our commitment to impartiality and efficiency is upheld through dedicated staff training, thorough audits, and active regulatory engagement. Additionally, we plan to expand our testing infrastructure and strengthen partnerships to advance diagnostic technology further. Looking ahead, our work will be crucial to continuing patient safety.”