Medical Devices
SZUTEST Konformitätsbewertungsstelle GmbH is designated as a Notified Body under the Medical Device Regulation (EU) 2017/745 (MDR) Our Notified Body number is NB2795. We are responsible for assessing the conformity of medical devices before they are placed on the market.
SZUTEST Konformitätsbewertungsstelle GmbH is a member of Team NB, the European Association of Notified Bodies for Medical Devices. Team NB represents the collective interests of Notified Bodies, fostering high standards and uniformity across the industry. Being a part of Team NB allows SZUTEST Konformitätsbewertungsstelle GmbH to stay at the forefront of regulatory developments and best practices, ensuring that we provide our clients with the highest quality certification and conformity assessment services. This membership signifies our commitment to excellence and adherence to the stringent requirements set forth by European regulations.
We provide comprehensive services in the field of medical devices, ensuring compliance with the latest regulations and standards. Our team comprises highly qualified professionals with extensive experience in medical device regulations. We are dedicated to maintaining the highest standards of quality in all our services.
To view our full scope, please visit the NANDO website.
Thank you for considering SZUTEST Konformitätsbewertungsstelle GmbH for your compliance needs. Contact us today to learn more about how we can help you navigate the regulatory landscape and ensure the success of your medical devices.
WHAT SERVICES DOES SZUTEST OFFER FOR MEDICAL DEVICES?
Our services include conducting conformity assessments according to MDR, performing audits to ensure compliance with regulatory requirements, assessing clinical data to confirm the safety and performance of medical devices, and reviewing technical documentation to verify compliance with MDR requirements.
The scope of the application includes Medical Device Regulation (EU) 2017/745 in Annex IX Part I, Annex IX Part II and Annex XI Part A. Performing audits to ensure compliance with regulatory requirements.