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amin-sadig started the topic Project Scope: When the timeline you have doesn't work in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
As many of you know, government regulations release update periodically. Sometimes its simple grammar and spelling fixed as well as quality of life wording fixes but other times, it is the inclusion of new regulations and requirements. What do you think should be done in the situation where the time needed to comply with the new regulation is not enough and the product that you have will not meet the regulation in time? Should an unethical non-representative “placebo” test be made to say that they are compliant with the new testing or functional requirement and then edited to a more representative and accurate test? What do you do if your device is not compliant with the new regulation or the facility that you have and your budget do not allow for the required tests to be done? What to do when the most sound timeline is too long but the shorter timeline cuts corners and has the risk of causing the entire project the collapse with critical failure? Where is line of ethics drawn in PM when certain cuts can be made to “optimize” the process from a company standpoint? ie. I finished the project under budget but you worked the employees like animals and kept it understaffed resulting in a high turnover rate.