ISO 13485 Medical Devices Quality Management
Quality is an important aspect of the Medical Devices industry. You may find that customers are often asking for proof of quality assurance from your organization. The medical device manufacturing sector has become more regulated everyday in which significant quality systems and product requirements must be satisfied.
The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose. This means that it will get harder for you to manage the quality of your medical devices operation as you are forced to comply with more regulations everyday. Though you may practice standard quality management within your organization, ISO 13485 is specific to the medical devices and thus will likely apply to you if you are within the industry.
Why you need to implement and certify ISO 13485?
Using the BSI Assurance Mark
Use the BSI Assurance Mark and demonstrate excellence to your stakeholders. Upon receiving your certificate, you will also be given a general guide and a BSI Assurance Mark for you to use, creatively. There are many ways to use this mark. You can choose to put it in:
If you are not sure how you can maximize the usage of your Assurance Mark, speak to us and we will help you figure it out.
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Further Information & Your Next Step