For purchasers and quality officers
Supplier file
Everything you need to assess VCM Medical as a supplier: company details, our role, documents, CE and MDR, service and data. For each item you see what you can download now and what you can request.
Company details
The details you need to register us as a supplier.
- Name
- VCM Medical B.V.Family business in Leusden
- Address
- Hamersveldseweg 135, 3833 GN Leusden, the Netherlands
- Chamber of Commerce (KvK) no.
- 97801267
- VAT number
- NL868237590B01
- Phone
- 033 434 50 60
- info@vcmmedical.nl
- Founded
- 1985
- Available
- Mon–Fri 08:30–17:00
- Customers
- Businesses and institutions only, not consumers
What we are and are not
What we are
- Distributor of Compumedics, Compumedics DWL, Nihon Kohden, Persyst and Echoson. We also supply accessories, such as EMG needles and EEG electrodes.
- Service partner: our own technicians install, connect, train, maintain and inspect, and handle faults.
- One partner for every brand we carry. We also service some other brands.
What we are not
- A manufacturer. The manufacturers design and produce the products we supply.
- The party that applies the CE marking. The manufacturer does that; see CE marking and MDR.
- A medical adviser. Product information and demonstrations are not medical advice; clinical decisions remain with your healthcare professionals.
Documents
For each document you see whether it is online. With a download button you can open it straight away. If it says “Request”, the document is not online yet: request it via the file form.
General terms and conditions
The terms for business customers: delivery, installation, software, maintenance and service.
Data processing agreement (model)
The model for agreements on personal data, for example for remote support. We sign a data processing agreement before we carry out work where we may have access to your institution’s personal data.
Privacy statement
What we do with contact persons’ personal data, which cookies the site uses and how long we keep data.
Information security
How we arrange remote support and which certificates from our manufacturers we can supply.
Chamber of Commerce extract
Extract from the trade register of the Dutch Chamber of Commerce.
Proof of insurance
Details of our insurance are available on request.
CE marking and MDR
In the EU, medical devices in principle need a CE marking. It shows that the device meets the European rules for medical devices, the MDR.
The manufacturer is responsible for the CE marking and for the conformity of its device. VCM is a distributor: we make the manufacturer’s documentation available.
What we make available
- EU declaration of conformity (DoC)
- CE certificate, where the manufacturer has one
- Instructions for use (IFU)
- Brochures and specifications
Which documents belong to your product, you find on the page of the system. If your document is not there, request it. Everything we supply, install and maintain is recorded per device in our own service system.
Per brand, the manufacturer’s certificates are on the page Certificates.
We publish manufacturers’ safety notices in My VCM; read more under Safety notices. You report an incident with a device via Report a fault. Articles 17 and 18 of the general terms and conditions set out what we expect of each other.
If we place a device on the market under our own name or brand, we have the obligations of a manufacturer. This is set out in article 16 of our general terms and conditions.
Service and faults
After delivery, our own technicians are your point of contact. The agreements that apply are laid down in your contract.
Data and security
Do not send us patient data, also not in fault reports or attachments. If our work may still give us access to personal data, we agree on this in advance.
Request the file
Your procurement file or requirements package? Send it to us. We respond within 2 working days.
Request the fileChecklist for your supplier assessment
You can request the following from us. Each button opens the file form with your choice already filled in.
Do not enter patient data in the form.