As a manufacturer you must ensure that your device meets the relevant regulatory requirements before being placed on 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.
Our Medicinal & Biologics team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise. With more than 200 years of overall combined experience, our team provides guidance on ancillary medicinal substances and blood derivative devices, as well as conformity assessments for MDR (Rule 18) and UK MDR 2002, Part II (MD) (Rule 17) for medical devices utilizing non-viable tissues of animal origin and for those utilizing tissues or cells of human origin and their derivates.
BSI Medicinal and Biologics team also offers expertise on ARTI/IVF legacy devices and emerging technologies related to medicinal, animal origin and biological substances.
