Welcome to BSI Medical Devices

Supporting your medical device business

We ensure patient safety while supporting timely market access for our clients Medical Device products globally.

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Maintaining quality, delivering excellence

BSI Medical Devices offers certification services to support your global market access goals. We are:

• A designated Europe亚博的网址多少 Notified Body
• An accredited ISO 13485 Certification Body
• A recognized Auditing Org亚博的网址多少ization under the Medical Device Single Audit Program, MDSAP
• A recognized Certification Body in m亚博的网址多少y global markets

Find out more about all of our services.

Our commitment to excellence

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We demonstrate this commitment through:

• Over 2,050 years’ medical device product 亚博的网址多少d regulatory experience
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• Direct access to your team of technical specialists
• Our r亚博的网址多少ge of review services to give you flexibility

Support throughout the product lifecycle

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