Quality management system certification
Kiwa Medical India
Our services for the Medical Industry
Medical devices are a heterogeneous category of products, such as active equipment, implants, reusable instruments, substances and materials, Sw, and more. All of them intended for use on humans and therefore their safety and performance are of vital importance. To be put on the market and traded in EU, medical devices must comply with pertaining European legislations. As Kiwa we can provide complete and reliable information on the appropriate medical devices certification process to undertake, and deliver qualified conformity assessment activities and related services.
Laboratory Capabilities
Navigate through Kiwa's extended landscape of laboratory solutions with our detailed testing directory, embodying the essence of more than 3000 capabilities within 80 laboratories around the globe.
Certification
Like every good business, you guarantee the quality you deliver. After all, your products, services, personnel and processes must comply with all the laws and regulations concerning safety, efficiency, control and sustainability. These values all come naturally to you. But convincing potential customers or clients of your good intentions matters, too. Our certification services help you to do this.
Training
We help you enhance your own and your employees' knowledge on a wide variety of subjects.
Inspection
We inspect your products, projects and processes to help you meet requirements and goals.
Testing
We offer a network of expert lab services around the world to ensure quality and safety.
Latest news
Position Paper of Team NB adopted: MDR Certification Process (including Pre-application, Application and Post Application phases)
The Position Paper “MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document” was adopted by the Team NB members and published on December 18th 2024. This Position Paper is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before and is aligned to the requirements of MDR
EU Commission Announces Four EUDAMED Modules as Fully Functional -MDR/IVDR Transition Periods Officially Begin
On 26 November 2025, the European Commission published Commission Decision (EU) 2025/2371, officially confirming that four key modules of EUDAMED are now fully functional. This announcement triggers the start of the transition periods for certain obligations under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
EU: Commission publishes second draft of GPAI (General Purpose Artificial Intelligence) code of practice
On December 19, 2024, the European Commission published the second draft of the 'General-Purpose AI Code of Practice.' Independent experts present the second draft of the General-Purpose AI Code of Practice, based on the feedback received on the first draft, published on 14 November 2024.
What is Clinical Evaluation Equivalence and does that apply to your medical device?
Are you considering substantiating the clinical data of your device based on an equivalence device? Do you have full access to clinical data for technical, biological and clinically similar devices and you wish to leverage that to prove compliance for another device? This article could help you get a feeling of whether this could be an option.
