Quality Policy

It is Vlow Medical's policy to provide products with a customer focus – to distributors, doctors and specialists for patient treatment – that comply with relevant legal and regulatory requirements. The management team is responsible for maintaining these requirements through an effective quality management system and comply to EN ISO13485 and MDR. This system provides a framework for establishing and assessing quality objectives.

MDR Registered Medical Devices

All Vlow Medical products have been registered under MDR 2017/745/EU Medical Device Regulation. Certificate number M.2024.MDR.1035, expiry date 25 Feb 2029

ISO Certificate

ISO13485 Quality Management System

Certificate of Approval: To certify that the management system of Vlow Medical BV, Quinten Matsyslaan 85, 5642 JC Eindhoven Netherlands has been approved by Lloyd's Register to the following standard: ISO13485:22016, approval number 00032658. The scope is the design, development, distribution and sales of syringes and needles. Expiry date: 23 Sep 2027.

Sustainability Rating

Ecovadis

Since its founding in 2007, EcoVadis has grown to become the world’s largest and most trusted provider of business sustainability ratings, creating a global network of more than 130,000+ rated companies.
An EcoVadis medal or badge is an acknowledgement of achievement relative to other assessed companies across the EcoVadis database. To be eligible for a medal, a company must achieve a minimum score of 30 in each of the four themes: Environment, Ethics, Labor & Human Rights and Sustainable Procurement. Vlow Medical has been rewarded with a Silver Medal, this means a top 15% score (85+ percentile).

FDA Approval Process

The 3Dose product has a 510(k) clearance, ref K250733, Decision date 7 Mar 2025.