Is regulatory compliance a matter of Quality or R&D?

A very frequent question mark…Discussed so far between R&D and Quality teams. Still remaining unresolved, but definitely a matter of collaboration.

A medical device, even starting from the idea phase, shall comply with the regulatory requirements. Unfortunately, this seems to be a limitation to the creative soul of R&D, but on the other side, regulations enlightens all the path to design a medical device that meets the user needs.

Medical device design projects are good examples for Project management challenges, since the majority fails due to the deviations in the regulatory compliances. Most of these cases are due to the missed requirements for the right choice of the raw materials, as well as the incorrect V&V testing planning, inproper documentation, leading to huge deviations from the target budget and timelines. And this is the good story… the bad side of the movie is the failure during use, which may lead to, even deadly results. And definitely, this has no excuse.

The current global regulatory developments show that this war will end up very soon, bringing up new collaborations between R&D and Quality teams to arise successfull and safe medical device projects on time and within the agreed budgets. So this is time to get prepared and establish close collaborative teams as of R&D and Quality where both parties understand their needs and support each other.