We spoke with Dr Marc Schulte, Head of Quality Management and Quality Management Representative (QMR) at Vanguard AG. After completing his PhD in microbiology, he joined Vanguard directly from university in 2021, initially managing the laboratory before taking on additional responsibilities in hygiene. Since March 2025, he has been leading the Quality Management department.
In this interview, he explains why quality management carries a unique responsibility in the medical device industry, the role audits play, and why effective quality management processes are often most noticeable when everything works together seamlessly.
How would you describe the role of Quality Management at Vanguard in simple terms?
Dr Marc Schulte: At its core, Quality Management ensures that requirements are met, both external requirements arising from legislation, regulations and standards, and the internal requirements we have established ourselves. We do more than simply monitor compliance. We help shape processes and ensure they work effectively in day-to-day operations.
This is particularly important at Vanguard because we operate in a highly regulated environment. We do not reprocess ordinary consumer products, but highly complex medical devices that are returned to use in sensitive clinical applications. As a result, Quality Management is always centred on safety, performance and traceability.
Dr. Marc Schulte, Head of Quality Management at Vanguard AG
Who is part of the Quality Management department?
Dr Marc Schulte: Our Quality Management department currently includes several colleagues across Vanguard’s sites in Berlin, Aschersleben and Friedeburg. In addition, two colleagues work in our in-house testing laboratory in Friedeburg.
The team brings together a broad range of expertise, including biology, biotechnology, molecular biology, chemical engineering, as well as technical and commercial disciplines.
Importantly, our work is not organised solely by site. Many colleagues hold central responsibilities for Quality Management processes across all locations, including change management, complaint handling, supplier management and trend analysis. This approach enables us to establish increasingly centralised and harmonised quality management processes.
What does a typical day in Quality Management look like?
Dr Marc Schulte: There is rarely such a thing as a typical day.
Part of our work involves routine activities that can be planned, such as evaluating complaints, conducting trend analyses, reviewing new or revised standards and regulatory requirements, and maintaining documentation.
At the same time, Quality Management must be able to respond quickly. For example, if a production machine does not operate as intended, it may result in a nonconformity. We then need to assess and document what happens to the affected products. Can they be reprocessed again? Must they be discarded? Has this issue occurred before? Which departments need to be involved?
Much of our daily work therefore revolves around organisation, structure and communication.
Which departments does Quality Management work particularly closely with?
Dr Marc Schulte: We work especially closely with Production, Research & Development, Engineering and our laboratory teams.
A good example is the environmental monitoring of our cleanrooms. Airborne microorganisms, particulate levels and water samples must be tested regularly. This requires close coordination across all sites between Quality Management, Engineering, our in-house laboratory and external laboratories.
The individual tests themselves are often not the most challenging aspect. The real challenge lies in coordinating schedules, sampling, transport, analysis and documentation reliably.
What role does Quality Management play in Medical Remanufacturing?
Dr Marc Schulte: Quality Management is fundamental to Medical Remanufacturing because the products involved must meet exceptionally high requirements.
Many of the devices remanufactured by Vanguard are highly complex medical devices. Some come into contact with blood or internal tissue and fall into the highest criticality categories.
These products cannot simply be steam sterilised like robust surgical instruments. They are often made from thermolabile plastics or contain sensitive technical components, requiring carefully validated cleaning, disinfection and sterilisation processes. At the same time, we must ensure that they remain both hygienically safe and fully functional afterwards.
Our Quality Management System provides the foundation that makes safe and high-performing medical devices possible. Through the department’s daily work, this foundation is maintained and ultimately supports the safe and effective treatment of patients.
What distinguishes Quality Management in the medical device industry from less regulated sectors?
Dr Marc Schulte: Vanguard operates under a Quality Management System certified to DIN EN ISO 13485.
Compared with more general quality management systems, the key difference lies in the focus. The primary objective is not maximum flexibility in meeting customer requests, but ensuring the safety and performance of medical devices.
This means that if a requested change could compromise the safety or performance of a product, it simply cannot be implemented. The essential safety and performance requirements always take priority. That is precisely what makes Quality Management in the medical device industry both particularly demanding and particularly important.
How can you tell when a Quality Management System is working well?
Dr Marc Schulte: A good Quality Management System is not one where nothing ever goes wrong. There will always be deviations, weaknesses and opportunities for improvement.
What matters is having clear mechanisms in place to deal with them: defined processes, cross-functional responsibilities and transparent documentation.
External audits provide one of the strongest indicators of performance. Vanguard is regularly audited by notified bodies and certification organisations.
What is the department currently working on?
Dr Marc Schulte: One of our main priorities is the continued centralisation of Quality Management documentation and requirements across all production sites.
This reflects Vanguard’s development across multiple sites with historically evolved structures. In the past, some documentation and procedures were site-specific. Our aim is to harmonise these and establish standardised processes that apply across all locations.
At the same time, we are continuing to digitalise our Quality Management System, making processes more efficient, transparent and independent of location.
What do you enjoy most about your work?
Dr Marc Schulte: What I enjoy most is the combination of organising, structuring and continuously improving processes.
Quality Management plays a central role within the company and interacts with many different departments. This provides a broad overview of the organisation and creates opportunities to actively shape how processes develop.
Another exciting aspect is that Vanguard still offers significant potential for further development. We can continue improving systems, simplifying processes and refining organisational structures. Having the opportunity to make meaningful improvements is what keeps the work varied and rewarding.
What achievement are you particularly proud of?
Dr Marc Schulte: I am especially proud that in 2025 we completed every external audit without a single nonconformity.
This was not only an achievement for the Quality Management department, but for the entire company. A Quality Management System only works when Production, Research & Development and every other department follows and embraces the shared requirements in everyday practice.
What would you say to people who see Quality Management as little more than a compliance exercise?
Dr Marc Schulte: Quality Management certainly involves documentation, procedures and oversight, but it is far from being a static box-ticking exercise.
In a regulated environment, the system is constantly evolving. Legislation changes, standards are updated and new requirements emerge. The Quality Management System must adapt and continuously develop in response.
Our role is not simply to enforce rules. We help ensure that the company can continue operating safely, consistently and reliably within a constantly changing regulatory environment.
Good Quality Management is...
Dr Marc Schulte: Clear, structured and straightforward.
It is effective when requirements are easy to understand, responsibilities are clearly defined and processes are not unnecessarily complicated. After all, a procedure document that nobody understands or reads is of little practical value.
The goal is to comply with regulatory requirements while implementing them in the most practical and user-friendly way possible.
Thank you for providing these valuable insights into the work of Vanguard’s Quality Management department.
