Whether your organization utilizes waterfall, lean, agile, spiral, iterative, or a hybrid product development lifecycle – what is the most effective software testing approach? The best description I ever heard was coined by Cem...
When should medical device internal audits be conducted? The timing of audits in a medical device development and manufacturing company can vary based on several factors. By John Rodriguez Medical device internal audits can...
Now that you have a great idea for a medical product, how do you develop your product and how much is it going to cost? By John Rodriguez This is a great question, and...
Now that you are in the development process for your medical product, have you considered where the product will be manufactured? By John Rodriguez Choosing a manufacturer is one of the key decisions your...
Facing validation of (non-product) software applications? This article is for you! Our clients have faced push back from the FDA during submissions, during audits and while attempting certification for the CE label – these...
