We are planning to take part of an already 510k cleared device (its energy converting part=motor)
to drive a new class I (510k exempt) device?
The new device shall undergo risk analysis, design input and V&V full testing for making 100%
sure it is safe for use and perform its intended use properly.
Do we mis any regulatory requirement which restrict us to do such a combination?
to drive a new class I (510k exempt) device?
The new device shall undergo risk analysis, design input and V&V full testing for making 100%
sure it is safe for use and perform its intended use properly.
Do we mis any regulatory requirement which restrict us to do such a combination?