The Vascular team specializes in any apparatus, appliance, implant, instrument, material or other article intended to be used in the arteries and veins that carry blood throughout the body or in the heart itself for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or injury, or in the investigation, replacement or modification of the anatomy in relation to the vasculature or the heart.
We are experienced in working with manufacturers of apparatus, appliances, implants, instruments, materials, or other articles intended to be used in the arteries and veins that carry blood throughout the body.
Where products require additional expertise, we collaborate with our in-house clinicians and technical teams in all areas from active implantable, dental and orthopaedic, to medicinal substances, devices utilizing animal tissue, and sterile medical devices.
BSI is able to offer CE certification services under the EU MDR and UKCA services under the UK MDR 2002 for vascular medical devices. Examples of products we cover include:
- Cardiac electrophysiology and ablation catheters
- Catheters for intravascular and intracardiac imaging
- Devices for the treatment of Abdominal Aortic Aneurysms (AAA)
- Devices for the treatment of neurovascular diseases including catheters, embolic coils, flow diverters, stents, and wires
- Devices for treatment or repair of structural heart defects or disease
- Drug-eluting stents, bare metal stents, and bioresorbable stents
- Embolic filters and IVC filters
- Guide catheters, balloon catheters, CVCs, introducers, filters, guidewires, PICCs, and related tools
- Renal artery denervation devices
- Transcatheter and surgical valves and related accessories
- Vascular closure devices
- Vascular grafts (textile and ePTFE) and stent-grafts
For more clarity on vascular and related medical devices, please refer to the MDR (EU) 2017/745 and the UK MDR 2002.