If your company makes medical devices, then you need to know how ISO 13485 can help you to develop a comprehensive management system for designing and making all medical devices.
How does ISO 13485 help with Quality control for your manufacturing business?
ISO 13485 requires that a business show that they have a quality management system in place that meets their customer’s requirements for their products and that this system is being maintained and running smoothly.
You must be able to meet the current regulatory and other requirements, as well as streamline your company’s ability to consistently manufacture a product with a safe design that meets both manufacturing regulations and your customer’s requirements.
If your medical device manufacturing company has a good quality management system in place that has been incorporated into your company’s goals, then this provides an excellent way to reduce and avoid disparity in your finished products. Being able to do that will save you money and make your company more efficient.
ISO 13485 Makes Your Medical Device Company Globally Competitive
Being complaint in ISO 13485 will also make you more competitive globally, as it is required in Europe and in Canada and without it you won’t be able to market your medical devices to the countries within the European Union.
The bottom line is that if you want your Medical Device manufacturing company to be able to produce a consistently well-made, safe and regulatory passing product, as well as be competitive world-wide, then you need to get ISO 13495 certified.