Earlier this year, my510k.com was founded on an idea, to extend the conversations I had been having with colleagues in the medical device community. It seems that there are few places online to connect and collaborate about the ongoing issues regarding the industry, government, and the world market for medical technology.

Many of the stories in the mainstream media are contributing to a public outcry for greater regulation in the medical device space. This has resulted in greater enforcement from the FDA.  As an industry, there is a great desire to constantly improve and innovate to bring new therapies and devices to market. As an industry we need a platform to address the public and the regulators, to show all that we are doing as an industry to remain vigilant for the pubic health.

With that I am excited to start the open pre-launch (Beta) of my510k.com as a new way to collaborate with colleagues in the Medical Device industry. Many of us who will use this site are certainly experts in our own right, with years of experience in the field. Many of us have developed strategies over time, and we have been able to get products to market.   The site has some new features like Messages, Groups and Blog features to allow members to communicate about issues that are importat to them.  Whether you are in Engineering, Marketing, Manufacturing, Quality Assurance, or Regulatory Affairs, we all have a stake in the 510k process.

 If you want to join  my510k.com  as a Beta user, please register onsite using OpenID or Facebook.  If you need an invite code for standard registration please inquire via email. Full launch is planned for later this Spring. For now, any inquires about the site can be directed to info(at)my510k.com. Thanks to all who have helped so far!