ISO 13485 Medical Device Certification
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What is ISO 13485 Certification?
ISO 13485 specifies the requirements for a quality management system that any organisation operating in the medical devices sector needs to demonstrate. Certification demonstrates your organisation’s reliability, proving your commitment and abilities to provide design, manufacturing, testing and sales services that consistently meet customer needs and regulatory requirements.
Getting certified with Kiwa
With increasingly strict regulatory requirements and expectations from customers and organisations throughout the supply chain, it is critical to demonstrate best practice in quality management processes – and ISO 13485 certification can do that.
By partnering with Kiwa, you can use ISO 13485 to ensure the products or services you offer in the medical devices field are in accordance with internationally accepted standards, helping you build trust with customers and meet legal requirements.
ISO 13485 and the MDR
The ISO 13485 quality standard helps suppliers of medical devices and related services comply with the Medical Devices Regulation (MDR). Kiwa UK co-operates with Kiwa Dare, Kiwa Cermet Italia and Kiwa Belgelenddirme Hizmetleri who are able to provide services for EU MDR.
FAQ
What is risk based approach in quality management system?
For medical devices the risk-based approach is crucial for patient safety to guarantee the devices meet the highest safety standards and regulatory requirements being sistematically identify and manage potential risks throughout the entire product lifecycle. Overall, a risk-based approach in a medical device QMS plays a vital role in ensuring patient safety, regulatory compliance, and the development of high-quality medical devices.
Is ISO certification mandatory?
No ISO standard is mandatory unless it has a law or regulation to make it mandatory. In the case of ISO 13485 it is not mandatory to be certified according to this standard, but all the quality management system will be audit according to ISO 13485 for the issue of the CE mark.
What is the Plan-Do-Check-Act in the ISO 13485 standard?
Plan-Do-Check-Act (PDCA) cycle is a fundamental principle in the ISO 13485 standard for Quality Management Systems (QMS) specific to medical devices. It's a continuous improvement model that emphasizes a cyclical approach to ensure the effectiveness of the QMS.
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.
Medical Devices in the UK
Medical Devices in the UK | Kiwa UK
