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About BSI Group
BSI is the business standards company that helps organizations all over the world make excellence a habit. For more than a century we have been challenging mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth. As a global leader in helping organizations improve, our clients range from high profile brands to small, local companies in 182 countries worldwide.
BSI covers a variety of industries from Aerospace to Construction, from Food to Information Security, but one of our Largest is Medical Devices.
Our Medical Devices Business stream’s mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.
As a medical device manufacturer, there are a number of regulatory requirements you must meet before you can sell your devices on the international market. It is essential that your certification body has the capability and expertise to support you with robust product and system certification reviews, to ensure patient and user safety.
Maintaining quality, delivering excellence
BSI Medical Devices offers certification services to support your global market access goals. We are:
- A designated European Notified Body
- The first UK notified body to achieve successful MDR designation
- An accredited ISO 13485 Certification Body
- A recognized Auditing Organization under the Medical Device Single Audit Program, MDSAP
- A recognized Certification Body in many global markets