02 June 2014
A unique look behind the scenes with Claire Banks, the business development manager at GX Design Engineers, part of the GX Group, as she talks more about the some of the standards that govern product development.
“In design engineering there is no one overriding standard,” says Claire, “rather each product depending upon how and where it will be used has standards governing practical guidelines.
As design engineers for the medical sector we would always adhere to ISO 13485 when designing a medical product; this is an international standard governing the design and manufacture of medical devices. By following the standards laid down in ISO 13485 guidelines we know that whatever we design it will pass the European medical device directives.”
Design consultancies like the Welsh based GX Group which includes GX Design Engineers; know there are a plethora of the standards which they must incorporate into their concepts. Keeping abreast of these changing standards and understanding the implications of each of them is an extensive job. When commencing on a new product design whether it is for a medical product or for the car industry the team at GX Design Engineers ensures that they adhere to current standard guidelines, where possible they even design a product to more than exceed requirements.
“At GX Design Engineers to ensure we are one step ahead of the guidelines we have always adopted ‘good manufacturing practices’ as a matter of course, often even when products have no standards to pass. We believe any good design should be a quality product, and be fit for purpose,” notes Claire.
“Where products have to comply with several standards, like the new product that we developed for Bayer Diagnostics the Clinitek Status, our design development team will ensure that all the material selection and the products functionality meet all the guidelines.”
There are even guidelines governing packaging for products sold with the European Community. For example, the European Parliament and Council Directive, 94/62/EC, brought into force back in December 1994, encourages the minimisation of waste material by asking manufacturers to prominently display the recycling options for the product along with the recognised recycling icon.
“Ultimately standards are put in place to safeguard the public,” concedes Claire. “When dealing with products that are destined to be used within the medical and scientific sector we are highly aware that they must be safe both for the user and where appropriate the patient.”
If you have an idea that you would like to explore with GX Group please contact Claire Banks on Claire.banks@gxgroup.com.