FAQ
What are disposable medical devices?
A disposable medical device is any medical product that is designed and intended to be used on one patient and then discarded after the completion of that treatment or a period of time.
They can be:
- Individually packaged
- Single use
- Clinically clean / Non-sterile / Sterile
- Typically used by trained physicians
- Used in hospitals / GP surgeries and homes
- Ideally low cost
- Made in traceable batches
- CE marked by a regulatory body
How long does it take to get typical medical equipment project from concept to point of sale?
Allowing about 12 months, including all regulatory submissions, is a good timeframe to work to.
Can you provide the product under CE mark?
Medical products will need to be manufactured using your own CE mark. We can introduce you to our preferred regulatory experts if you require additional expertise.
Do parts that subcontractors supply need to be made in a cleanroom?
Ideally, yes, but depending on what the part is and its origin, cleaned can be ok.