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hc255 replied to the topic R&D vs Quality in the forum Quality Control and Quality Assurance 8 years, 2 months ago
Quality is put in place to police R&D and other departments to ensure that effectiveness and suitability of processes are maintained across all levels. With that being said, both departments are crucial to the business. I believe that at the end of the day both departments must reach a consensus in order to continue progress. One cannot strive without the other. R&D should understand the goals associated with the Quality department but act in favor of compliance in order to keep the FDA in good hands. Quality should advise R&D the right measures and keep them informed of such changes in standards such as ISO 13485 to ensure that everything is being kept up to par so once again FDA is not concerned. Regardless, this dynamic needs to be a collaborative effort to maintain a win/win situation.