Medical Devices

Medical Device Expertise

Our global expertise for your medical device.

Our Experts

Top medical device manufacturers work with BSI because we understand the challenges manufacturers face in bringing compliant products to market efficiently and safely

We work with a significant number of manufacturers, with a variety of products from novel to complex to high risk.

We work with companies just starting out to large multinationals. And we understand that each company and product are at different stages and have unique needs and priorities.

Our comprehensive review process combined with our world-leading experience as a Notified Body will ensure that your conformity assessment process is both efficient and robust.

Why choose BSI?

We are a global organization, trusted and recognized around the world

It is critical to work with a Notified Body that understands the industry and has the experience to review your product’s readiness for market.

AIMDs are subject to rigorous regulatory controls both pre- and post-market. The regulatory controls set out in the MDR also apply to any accessories that are used to enable the device to operate as intended, such as, battery packs, controllers, implant kits, leads, programmers, refill kits, and software applications.

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SaMD and “Software in a Medical Device” (SiMD) are not defined in MDR, IVDR. MDCG 2019-11 defines “Medical Device Software” (MDSW) as encompassing all types of software with a medical purpose or acting as an accessory to a medical device, including software embedded within a dedicated hardware medical device.

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The integration of AI into our daily lives is growing apace. Continual investment and innovative AI development will shape the future of society and fuel progress towards a sustainable world. We enable organizations who develop or deploy AI products or services to do so safely and responsibly, in-line with emerging regulation.

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We truly understand the challenges that medical devices manufacturers face bringing compliant IVDs on to market efficiently and safely. Whether you're starting the certification process or looking to transfer to BSI, we offer a range of flexible product review services providing you with efficient pathways to bring your device to market.

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We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market. Orthopaedic and dental devices are generally characterised as devices intended to treat or reconstruct skeletal or dental tissue.

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We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

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We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

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As a manufacturer of a medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market. It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

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Our microbiology technical specialists have extensive experience in sterile medical devices and can support you through the process of certifying your device.

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Our Medicinal & Biologics team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise.

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