Placing your vascular medical device on the market

As a manufacturer of a vascular 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.

  • Notified Body - BSI The Netherlands (2797) - reviews medical devices to ensure their conformity to the European Directives and Regulations
  • Approved Body - BSI UK (0086) - provides conformity assessments under the new UKCA Scheme

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.

Martiza Carballo

Meet our experts

As a manufacturer of vascular medical devices, one of your biggest challenges in breaking into, or continuing your success in this market is navigating the regulatory process efficiently. Strong, statistically relevant clinical evidence demonstrating the safety and performance of your device to confirm clinical claims, intended use and intended patient population for the device is essential to ensure a successful outcome of your application.

Our vascular Technical Specialists are product experts who are highly trained in working with vascular medical device manufacturers and understand the specifics of these complex devices. We are experienced in working with apparatus, appliances, implants, instruments and other articles intended to be used in the vascular system. We also provide conformity assessments for medical devices for the heart itself used in the diagnosis, prevention, monitoring, treatment and alleviation of disease or injury as well as, in the investigation, replacement or modification of the anatomy in relation to the vasculature or the heart. Where additional expertise is required, we collaborate with our inhouse subject matter experts from all medical devices areas.

Vascular brochure