Drug device combination products
If you are a manufacturer of drug-device combination products, you need to be aware of the changes in Article 117 of the Medical Device Regulation (MDR), and what it means for you.
Devices and technologies
Devices and technologies
Our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies
Our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies
Our global expertise for your medical device
Over 95%* of the 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.
*95% of the top 20 manufacturers as listed by MedTech Insight, Pharma intelligence.
