Important role in the distribution of medical products within MDR underestimated

Vision Medical Company opts for demonstrable quality

  • 18 March 2024
  • 5 min

The Medical Device Regulations for medical products also affect the distribution companies in the healthcare chain. Reason enough for Vision Medical Company, a total supplier for primary and secondary care, to take QA/RA seriously and to engage ICT Group to be more than MDR compliant. 


QA/RA and MDR compliant

The legislation surrounding the Medical Device Regulations (2017/745 EU, hereinafter referred to as MDR) places high demands on the developers and manufacturers of medical products. What the market underestimates is that these products are often distributed worldwide and buyers sometimes only receive a product months after the order. How do they know if the product still complies with the MDR and what happened to it along the way? Medical (sterile) consumer items, for example, must be transported carefully, for which the experience of the transporter is very important. In that case, a CE certificate is not sufficient. It is the importer and distributor  who oversee the entire chain and who can ensure supervision and compliance with the MDR. Robin Bijdevier, Managing Director at Vision MC, believes that their role in this is so important that they invest in it purposefully.


Integrating MDR into processes

Robin Bijdevier: "A large number of hospitals and various private clinics in the Netherlands are our customers. Quality has always been of paramount importance to us. Since the beginning in 2003,  we have met ISO9001 for our procedures and management processes. 

But a QMS (Quality Management System) can be used by anyone and is not industry-specific. We were specifically looking for a connection with healthcare and therefore started writing procedures ourselves, for example for the shelf life of sterile products. The change in the law for medical devices was the reason for us to arrange our affairs properly formally. Think of product labels with specific requirements  for storage in our warehouse. As a distributor/importer, we have to maintain these conditions. In addition, we have  been given a more extensive obligation to report customer complaints to producers , authorized representatives and authorities. So we also have to monitor the traceability of the entire chain."

Quality is paramount

"That's why we called in Gerrit Lindenschot from ICT Group. Gerrit is a true senior QA/RA consultant. Precisely because we have been working on quality assurance for so long, a kind of business blindness can easily arise. Gerrit's strength is that, as a relative outsider with a lot of experience in this field, he takes us along and shows us in great detail how we really stand and what steps are necessary. We need his knowledge of the MDR to integrate MDR into our processes. In addition, Gerrit is very committed, easy to get along with and extremely knowledgeable. We can always count on him and trust him in our pursuit of the highest quality and to at least meet the requirements of the MDR."

“We stand for quality and want to stay ahead of the curve. ICT Group is an indispensable support for us in this regard.”

Robin Bijdevier
Managing Director at Vision Medical Company
Robin Bijdevier

Sparring partner

"Gerrit first carried out an audit, a gap analysis, of our current QMS and determined which actions we can take to fulfil our role as distributor and importer within the MDR as well as possible.  Based on the results, we set up a project that we are now rolling out step by step. Gerrit acts as a sparring partner and plays a leading role in drawing up the procedures. He thinks along with us, asks the right questions, presents cases and helps to unravel the case. We have a kind of continuous evaluation moment with each other. What I am very happy about: he prevents us from making it more difficult than it is, not thinking too black and white between theory and practice. Gerrit keeps it understandable for everyone. He also regularly visits hospitals and sees how things are going. That knowledge and his honesty are very welcome to us."

Continuous optimization

"In just under 2 years, we have already come a long way and are now completing the final procedures. Qualitatively, we have really made progression. In the future, we want to comply with ISO 13485, so that we are also compliant with ISO 13485 and MDR as an importer and distributor. We continue to optimize. Gerrit's critical eye and his pragmatic way of working help us with this. He is transparent, open and cheerful, so that we are in the right flow together. As an importer/distributor, we want to  oversee the entire chain and know and control the processes and their effects on products. We are taking the lead in this so that we can demonstrate to customers that we understand their needs and that the impact of MDR is in safe hands with us. Gerrit and ICT Group are an indispensable support for us in this."


About Vision Medical Company

Vision Medical Company is based in Uden and has been active in the production and distribution of medical consumables since 2003. They provide solutions for Anaesthesia, Surgery, Electrosurgery, Neonatology, Urology, ICU, Cardiology, Radiology, Emergency and Nursing Departments. Due to their considerable stock capacity, they can guarantee continuity of supply for their contract customers, which gives them a distinctive market position.

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