BSI Group - Meet the world with confidence

Our 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.

The challenges medical device manufacturers face in today's highly competitive marketplace make it essential to ensure that your product meets all regulatory and quality requirements before launch. It is critical to work with a leader that understands the industry and has the experience to review and confirm the products' readiness for market - efficiently, reliably and promptly.

BSI is a company that has been leading the way in assisting manufacturers to navigate through the maze of regulatory requirements.

We are a respected, excellent notified body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers around the world. For more than 100 years, BSI's expertise has provided an assurance of safety and quality to manufacturers; we now operate in over 182 countries.

The best route to getting your products to market

As a client of BSI, you will have confidence knowing that we conduct robust, comprehensive assessments that will stand up to scrutiny.

We are well known worldwide for our fast, efficient and predictable service, meaning you will know what to expect with timely results and no surprises. This creates the best route to market for you.

You will appreciate our unique combination of advanced technological knowledge and accessibility. Our experts make themselves available to clients throughout the process, inspiring a sense of connectivity. You will have direct access to your named scheme manager.

BSI works with every size of manufacturer. From novel to complex, commodity to high risk, new start-up to multinational, BSI understands that different device manufacturers at different stages have unique needs and priorities.

BSI combines an expert understanding of local and regional medical device regulatory issues with the efficiency and cost-effectiveness of a global network of industry resources. By working with BSI, our customers can count on more than just technical capabilities and testing capacity.

Our medical device team contains more than 150 global experts in medical technology. Our team members have an average of 20 years of industry and regulatory experience - many of them holding patents in their respective fields. With dedicated experience in all classes of device, our team can offer your organization a total solution to navigate the regulatory pathways and demonstrate continued compliance.

Consolidated clinical and regulatory planning will assist your company to maximise resources and minimise time to market, and reduce the risk of costly development reworks. It is never too early in the product development cycle to start planning, so come and find out more about how BSI can facilitate your regulatory journey.

We understand that obtaining certification and compliance can be a long and complicated journey. There are often 'shortcuts' - easier paths to market readiness - that arise, but your organization should never settle for a notified body whose focus is on short-term solutions.

When you collaborate with BSI, you'll benefit from more than exceptional product and regulatory expertise: our team of dedicated professionals provides comprehensive support. Our solutions are tailored to your goals to ensure cost-effective certification that stands up to scrutiny and supports your long-term goals.

When choosing BSI you can rely on our five core values:

  1. Product expertise - our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies.
  2. Global access - we operate in over 150 countries with more than 100 years of experience and offices around the world to serve you.
  3. Speed-to-market - providing flexible solutions for manufacturers needing accelerated pathways to global markets.
  4. Confidence - our stringent review process combines speed with experience, integrity, independence and predictability.
  5. Partnership - we focus on establishing a partnership with each client so we can work together to meet their goals.

A resource for excellence

Medical device newsletter service - Keep updated on what's happening in the industry and changes in regulatory and quality requirements. You can take advantage of this free service by signing up at our website.

Informational webinars - We offer a wide variety of interactive multimedia presentations allowing convenient participation via a web-based interface.

Standards - BSI British Standards delivers leading-edge best practice solutions through the development and publication of more than 34,000 standards and related products.

Your resource in worldwide compliance, visit\medical - to start your journey.

Use the following link to see the resources of BSI Group Germany

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