How Can Medical Device Manufacturers Increase Product Quality?
Medical device manufacturers play a critical role in the US healthcare industry by providing essential tools to healthcare providers. The quality of these devices is of utmost significance, as they directly impact patient safety. However, ensuring consistent product quality can be challenging. From design and development to production and distribution, each stage of the manufacturing process presents […]
4 ISO 13485 Changes That Can Help You Gain A Competitive Edge
The 2016 update to the ISO 13485 standard brought about some notable changes for companies to focus on. If your company has been underperforming, it might be time to lean into the requirements of the standards and capitalize on these changes. Not only will you ensure that the medical devices you’re manufacturing are of the […]
How to Structure the ISO 13485:2016 Internal Audit
If your medical device company is considering implementing the ISO 13485 quality system, you’re probably still in the early phases of familiarizing yourself with the requirements.
How to Gain ISO 13485 Certification for your Medical Device Company.
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 […]