BSI would like to correct any recent inferences in the media linking BSI Kitemark to medical devices. The Kitemark is a BSI certification mark but is not used with implantable medical devices.
Medical Devices are regulated by EU directives. Responsibility to ensure the directives are fully implemented falls to each member state and in the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Under the auspices of the MHRA, BSI is an independent review body that conducts conformity assessments to the relevant EU Directives.
We are a world-class Notified Body providing rigorous regulatory and quality management reviews and product certification for medical device manufacturers. Establishing a long-term partnership with each client is a vital part of our philosophy and we focus on open communications throughout the review.
Our one-stop shop approach offers a wide range of programs and services designed to help move medical devices to global markets swiftly.
We have been doing business in more than 100 countries for over 100 years and we specialize in high-risk, invasive, combination and implantable. Our team of healthcare experts understands your business, as well as the challenges of the global marketplace and we are committed to providing you with the highest standard of service.
Services offered by BSI include: