Vascular devices are medical devices and their accessories that are used in the arteries, veins or the heart itself, to control, diagnose, monitor, or correct disease, injury, or other conditions. This vasculature encompasses the cardiovascular, peripheral vascular, and neurovascular anatomy. These devices may be metallic or polymeric and may utilize animal tissues or be used in combination with medicinal substances.
Navigating the complex regulatory landscape is crucial for manufacturers of vascular and vascular access devices aiming to enter European and UK markets. Compliance with the Europe Medical Device Regulation (EU) 2017/745 is mandatory to obtain the CE Mark, while meeting the UK Medical Devices Regulations 2002 is required for the UK Conformity Assessed (UKCA) mark.
As an approved EU Notified Body and UK Approved Body, we provide comprehensive services to ensure your devices meet these rigorous standards – from certification to quality management system (QMS) certification and beyond.
Ensure your vascular and vascular access devices meet all regulatory requirements
We enable you to:
- Gain market access
Navigate the EU and UK regulatory requirements with confidence.
- Confirm compliance
Ensure your products comply with the Europe Medical Device Regulation and the UK Medical Devices Regulations.
- Acquire the CE Mark
Achieve the CE Mark through our Notified Body certification.
- Achieve the UKCA mark
Gain the UKCA mark through our UK Approved Body certification.
- Update your skills and knowledge
Benefit from our training and webinars to understand market access requirements and develop acceptable technical files.
- Certify your quality management system
Gain certification for your medical device quality management system against ISO 13485 standards
Ready to gain market access in Europe and the UK?
Contact us today to learn more about our vascular devices certification services and how we can help you achieve compliance and certification.
FAQ
Vascular access devices (VADs) are a type of vascular medical device that are inserted into veins through central or peripheral vessels for therapeutic or diagnostic purposes. These include central venous pressure reading, blood sampling, total parenteral nutrition, administration of medicine and fluids, and blood transfusions.
Contract manufacturers play an important role in medical devices. Manufacturers can open new markets with a certified quality management system (QMS).
201 Route 17 North,
7th floor,
Rutherford, New Jersey, 07070,
United States