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 for like-minded quality 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.
Thank you for joining us on this journey.
Our commitments
No AI
AI is obviously going to be a fixture of the world from now on. We won’t dissuade anyone from using AI to help understand regulations or quality and have used it ourselves to learn niche regulations.
That said, nothing on this site will ever be written by AI. If you want something from AI, you have the ability to ask it yourself. The goal of this site isn’t just to explain standards and regulations, but to utilize experience that can only be gained from professional experience to teach how companies implement these processes.
No Ads
Don’t you hate when you visit a blog to try and learn something and spend half your time trying to move through the article without clicking on various ads and pop-ups? We do as well, which is why this site will never be a neglected wall for random companies to cover in advertisement graffiti.
We want you to enjoy the time you spend on the site. Part of that enjoyment comes from reading the content on a clean and clear space.
Understand this does not mean that we will never feature a sponsored article or featured links from partnered companies. But no companies will be able to post giant banners on this site. All sponsored articles must contain relevant information we believe our readers can learn from, and all features will come from companies who we partner with and trust.
Does this mean there is less revenue coming to the website?
Yes. Especially as a niche blog, we could generate a healthy amount of revenue from posting ads. However, in our opinion, this is not a worthwhile tradeoff for ruining the feel of the site.
How can I support the website?
We spend a significant amount of time writing and editing articles to try and create good and helpful content. If you like what you are reading, please comment and share articles on social media to help us help more people 🙂
We are also able to do consultations and training on anything related to medical device Quality Management Systems. If you are interested, please reach out to info@hardcoreqms.com