Experienced medical device engineers know how challenging it can be to meet validation criteria and to maintain validated processes!

Process validation success starts way before you write your validation plans.  Our consultants have learned first hand through trial and error how difficult it can be to pass validation requirements when specifications are unreasonable.  What should you do if you are faced with such a situation? Design engineers usually won't fudge because they passed all DV requirements.  So figure it out!   Our consultants have been on both sides of this discussion and can provide recommendations and ideas to your design and process engineers on how to increase your first pass success rate.