Hello and welcome to Hardcore QMS! This site was built by quality and regulatory veterans from the medical device industry who want to share their knowledge and provide value to the QA community.
We created this site to be a meeting ground for like-minded quality assurance and regulatory professionals to learn, share ideas, and find whatever entertainment we can in this world of standards and regulations. The site will focus on ISO 13485 and FDA regulations for medical devices. Eventually, we hope to expand to related standards such as ISO 9001 and AS9100 as we grow.
We do not intend for this to be a static site that just posts blog posts into the ether. Accordingly, feel free to comment on any of the posts. We will almost certainly respond, provide feedback, or incorporate your ideas into future posts. The team here at Hardcore QMS knows that many of the things related to quality are open to discussion. We are happy to explore all ideas to make sure we are providing the best content possible.
Thank you for joining us on this journey.