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Vanguard – Introduction

Founded in 1998, VANGUARD AG is a Berlin-based medical technology company that develops CE certified, state-of-the-art, high-quality remanufactured single patient use medical devices.

We guarantee the sterility and functionality of our remanufactured devices in full accordance with the specifications of the original products and in compliance with the requirements of the MDR 2017/745/EU.

Our standing in the market is proof of the exceptionally high-quality standards we maintain: VANGUARD is the European market leader in the remanufacturing of high-quality medical devices.

Facts and Figures

Process Steps

Vanguard guarantees professional remanufacturing to the highest standard with product-specific validation methods applied in our state-of-the-art production facilities.

1. Collecting used medical devices

Vanguard works in partnership with healthcare facilities to ensure the devices are collected effectively and safely.

2. Pre-production

We identify, pre-clean, disinfect, decontaminate, laser mark and clearly label all devices collected. Our partner institutions that supplied the used devices are informed about the medical devices that have been received and their status.

3. Processing

This stage includes disassembly, cleaning, disinfection, re-assembly, and 100% product testing for their functionality, including testing the full range of their parameters.

4. Packing sterile goods

The remanufactured products undergo visual checks, final disinfection, machine-applied protective packaging, sterile packaging, before final sealing and inspection of the sealed sterile packaging.

5. Sterilisation

Sterilisation is carried out in accordance with required testing protocols including product inspection and the release of devices only upon completion of a microbiological evaluation.

6. Shipment/delivery of medical devices ready for use

Finally, the sterilised devices are labelled, inserted into external packaging and, following inspection, the medical devices are released for distribution. The packaged devices are then shipped to our customer partners. The products are sorted according to customer specifications, packed in dispatch boxes and handed over to the shipping company.

Innovation

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Advanced Irrigation – irrigation concept for cooled ablation catheters, with irrigation from the proximal to distal end allows the elimination of all residues in the lumen.

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End to End Volumetric Monitoring the processing of media flowing through the lumen of each individual medical device and in each process step of the cleaning and disinfection process.

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Standardised tests of each electrode for leak-proof integrity and function ensures no leakage of fluids into interior of device and device is free of residues.

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Microbiological testing procedure with the reference OPA method according to EN 15883 implemented as standard practice to ensure and document the effectiveness of the cleaning procedure.

Management of VANGUARD AG

MARCUS H. BRACKLO

Marcus Bracklo has served on the board of Vanguard since December 2008, first as a non executive and since March 2018 as CEO. He has over 30 years of experience in the healthcare industry. After graduating with a Masters Degree from the London School of Economics in 1987 he worked for the OECD in Paris, before joining Price Waterhouse where he qualified as a chartered accountant and became a partner. He worked for 15 years as a consultant to healthcare companies. Subsequently he established the healthcare investment banking business of Sal. Oppenheim which he led as Managing Director from 2001 to 2007. In 2007, he founded Baigo Capital GmbH, an investment and consulting business specialised in the healthcare industry. Baigo Capital is a shareholder of Vanguard AG.

Vanguard AG
Landsberger Str. 266
12623 Berlin
Germany

 

Customer Service

+49 (0) 0800 82648273
service@vanguard-healthcare.com

Notified Body

BSI Group The Netherlands B.V.
Notified Body CE 0086

ECM
Notified Body CE 0481