Actionable and educational content on medical device product development, quality management and compliance.

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Testimonials


"Dear Mr. Speer & Greenlight Guru,

I was hired by the FDA in 1976 to help implement the new Medical Device Amendments to the FD&C Act. I left FDA in the late 1980s and worked for several large medical device manufacturers to help them with compliance issues. I have seen literally hundreds of documents prepared by QA/RA departments of large device firms and by numerous consulting firms.

I just wanted you to know that I have not seen anything that equals the quality of content in your presentations. I am Impressed. I may take advantage of more of your free downloads.

Thanks, and Keep up the Good Work!!
" - Clyde B., President & CEO

"Really appreciate the weekly updates. They are very educational." - Monisha B., Executive Director


"Thanks, Jon. I will use this content as a reference for the course I am teaching at Carnegie Mellon, “Medical Devices.- Jim A., Professor, Biomedical Engineering


"Jon, I just want to say thank you for creating the Greenlight Guru blog. It has helped me a lot. I dont have any department head to teach me and I inherited this job from a previous RA so I'm learning everything on my own. For me, your blog has been my main teacher. I read it everyday. Never miss. Everytime I feel like I cant do this job anymore, I turn to your blog. Thank you again." - Ajwad, QA/RA


"Jon, Just wanted to say as a courtesy, I am a reader of your terrific site, friendly offerings of well assembled docs, presentation, and blogs. Thank You." - Jerry K. Vice President, Operations


"Hi Jon - I am a young medical device engineer and an aspiring entrepreneur. I love your blog and am constantly reading it to gain a better understanding of medical device product development. Looking forward to more of your articles." - Luke P., Engineer


"Hi Jon, I am a Product Development Engineer who is trying to get a handle on all of this. I come from academia where I made countless medical device prototypes as a Biomedical Engineering graduate student, now I have been learning to hone my industry skills. Your content has been a great crash course. Thanks!" - Kameel A., PhD, Product Development Engineer


"I really like the direct and clear method on risk management explanation by Greenlight Guru. Much appreciated." - John C.


"Dear Mr. Speer, I have been frequently reading your articles for the past two months. They have helped me improve my skills and implement the knowledge in my current job. Your blogs and articles are really good and make it easy to understand the base concepts. I would like to thank you for your effort. Regards." - Sugumar P., Sr Mechanical Engineer


"Hi Jon, Love your content. Great work. Thanks." - Kim M.


"Hi Jon! I'm actually a soon to be college grad who has some experience from internships with medical device companies. I'm prepping for an interview with a target company on Friday and your content is a very refreshing approach to topics that would otherwise be considered tough to self-teach! Thanks for the great content!" - Justin N.