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
Kiwa Supports India’s MedTech Ambitions at GRIT Gandhinagar 2026
Kiwa was proud to participate in the GRIT Gandhinagar 2026 conference, “Gujarat to Global: Empowering the MedTech Ecosystem,” held on 23 June 2026 in Gandhinagar, Gujarat, India. The event brought together policymakers, regulatory experts, industry leaders, and medical device manufacturers to discuss how India’s rapidly growing MedTech sector can strengthen its position in global markets.
MDCG 2026-4 is published: new transitional process for SSCP Management in EUDAMED
The MDCG published MDCG 2026-4 – Management of SS(C)P in EUDAMED after mandatory use in June 2026. The document explains how SSCP documents will be managed in EUDAMED during the transition following the start of mandatory use on 28 May 2026.
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).
