Approval management in healthcare product

VELA now uses DELTA

The Aalborg-based company VELA now uses DELTA to ensure that the company does not receive any unpleasant surprises when it comes to testing and product approval. This is termed "approval management".

Public sector tenders or not

What is the difference between a test that is certified and one that is not? Well, as far as the Aalborg-based company VELA is concerned, the difference is one of whether or not the company can take part in public sector tenders, both in Denmark and in other countries.

About VELA

VELA produces specialised furniture and wheelchairs for the elderly and the disabled. The product catalogue contains around 25 electric wheelchairs which, among other things, are covered by EMC requirements.

Markets and customers

Typically, the chairs are not sold directly to the users but rather to public sector aid device centres in Denmark, Norway, Germany, the Netherlands and other countries in Europe. Often, the sales are made in connection with tendering rounds, in which a number of manufacturers bid to supply, for example, electric wheelchairs.

Customer requirements

"We took part in a tendering round where we found that, because our EMC test was not a certified one, we were not qualified to participate. That experience led us to decide to focus even more on ensuring our products lived up to the testing and certification requirements demanded by our customers," explains Michael Vestergaard, development manager at VELA.

Accredited test as competitive parameter

"Compared to just two or three years ago, there is much more focus today on ensuring that products are not just tested but also tested by an accredited testing supplier such as DELTA. In the tenders that we have taken part in, having the tests certified has been an important competitive parameter. If not, as we found, you risk not being allowed to take part in the tendering. What is more, we find that some suppliers require our products to be able to meet new, more stringent requirements for the whole period of the contract, typically three or four years into the future," Michael Vestergaard explains.

Systematic review of all products

After the experience of losing out on taking part in the tendering process, VELA decided to have a systematic review carried out on all its products in order to find out how each product had been tested, and to what degree they lived up to both existing and known future requirements.
"We got DELTA to review all our products, which included both EMC and other technical parameters. Therefore we are now assured that all our products have been through all required tests," says Michael Vestergaard.

Requirements when purchasing

Having close on 500 sub-suppliers, communicating both the current and future requirements to everyone who provides components for VELA's electric wheelchairs is a continuous task.
"When you begin to work more systematically and make the requirements more stringent, it naturally has a knock-on effect on all the manufacturers who provide parts and components for our wheelchairs. Either they need to ensure that their components meet the limit values or, alternatively, they are replaced by other suppliers," says Michael Vestergaard.

VELA uses DELTA approval management

Today, VELA has an agreement with DELTA on so-called "approval management". DELTA's task is simply to see to it that VELA does not meet with any unpleasant surprises, both in terms of EMC and other technical requirements, and to ensure that the company is always at the forefront in the development of requirements and test types and forthcoming changes to these.
"It would be a colossal task for us to monitor all the testing requirements that our products are subject to, or might be subject to. So, we pay DELTA to look after all the tasks relating to ‘approval management' - in other words, all tasks concerning approval of our products," says Michael Vestergaard.

The security of having DELTA behind you

For VELA, EMC is one of a number of important parameters when it comes to testing and product approval.
"It gives a feeling of security having DELTA behind us when it comes to the EMC status of our products. Naturally, in our daily development work we have to be careful that the components we use can be used in terms of the EMC limits. It can be expensive in the long term if you have spent six months making a prototype and it turns out that it doesn't meet the requirements," says Michael Vestergaard. He continues:
"We have found DELTA to be extremely professional, and they have even invited tenders from other testing suppliers for us, even though they themselves carry out these tests. We find this to be very customer-oriented," he says.