Design and development (ISO 13485:2016 clause 7.3)
Design Control is almost the trickiest part,
Santa and his Elves need to be talent and smart.
To ensure they don’t miss an important thing,
planning and execution is everything.
The elves prepare the final Design Review,
and discover they missed a little screw.
When the design input is 100 % reached
The product can soon be safely released.
Don’t forget the clause 4.2.3 in ISO13485,
and upload the Medical Device File on the drive.