Do you have a brilliant design idea or did you find a solution to an urgent production issue and you want to get straight to the practical implementation? Or don’t you have time to bother with paper work? Remembering all the details later proofs to be difficult and those details may be the relvant for the authorities to prove that your medical device is safe and effective. If it is not written, it does not exist.
It is worth to take your time to document and do it just in time. Knowing the requirements regarding the content helps to reduce documentation efforts. Aligning the scope of the different documents enables you to use synergies in putting together the various files for the authorities. If you want to control the design of your medical device but also the respective medical device documentation, contact knoell to get support on how to establish and maintain the relevant regulatory documentation in the most efficient way.