11th April 2014
April’s Expert Advice
Working to high standards
Why Good Manufacturing Practices matter
A look behind the scenes with Claire Banks, the business development manager at GX Design Engineers, part of the GX Group, exploring some of the standards that govern product development.
“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. For example, when working with the medical sector we would always adhere to ISO 13485 – 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. Whichever design agency that you choose to work with they should inform you about the guidelines.”
Design consultancies like the GX Group, which includes GX Design Engineers, know there are a plethora of high 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. The design company you work with will be aware which guidelines a new product must meet, they will build it into their design process. Infact, where possible most even design a product to more than exceed the requirements.
“At GX Design Engineers to ensure we are one step ahead of the guidelines. We have always adopted ‘good engineering practices’ as a matter of course. We strongly believe any good design should be manufactured to a high standard, and be completely fit for purpose,” notes Claire.
“Where products have to comply with several standards, like the plasma based product that we developed for Gyrus Medical the Rhytec Portrait ‘R’, our product 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 within 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,” says 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.