BSI Breakthrough Device (BtX) Pathway

Specifically designed to support the timely conformity assessment of breakthrough medical technologies.

Reinforcing BSI’s commitment to support and Innovate medical technologies

A more agile and responsive assessment process to access the market efficiently while maintaining the highest standards of safety and compliance.

We have established the Breakthrough Device Pathway. A service specifically designed to support the timely conformity assessment of breakthrough medical technologies.

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Discover MDR certification with BSI and associated topics.

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Discover IVDR certification with BSI and associated topics.

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Demonstrate your ability to provide safe medical devices and services that consistently meet customer demands and applicable regulatory requirements.

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Through MDSAP, medical device manufacturers need only to be audited once in order to comply with the standard and regulatory requirements of up to five different medical device markets.

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Clinical evaluation is an ongoing process that starts during device development and continues throughout its lifecycle.

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