British Standards Institution

BSI is a very tough but fair notified body. We have been using them for three years and I really feel that our facility benefits tremendously from every audit. During the audits, I feel that they are not there just to find problems but to help find solutions to fix the problems as well. As our notified body, they also provide CE marking for our products. We always use their dedicated review service. While it costs more to use, it is a way to significantly cut down on the approval time. I think hands down, BSI is the best notified body.

Strengths: BSI is the among the most respected ISO-13485 notified body in the world.

Needs to improve: More expensive than other notified bodies.

BSI is an industry benchmark relating to audits and notifying entities. They provide thorough audits, which you want, to ensure your product's integrity, and do their part to offer solutions instead of just comments. Expert team offers quality client care and interaction. Objective analysis with accurate findings, you are not going to receive water downed filler verbiage. Will continue to contract as their reputation speaks for themselves.

Strengths: product testing, thoroughness, quality, customer service, expert staff

Needs to improve: Pricing could be better