Useful Information and FAQ's

For answers to questions such as:

• What is an FDA 510 (k)?
• How do I get FDA approved?
• What is a Predicate Device?

For information on:

• The new UK conformity marks
• When you should use UKNI marking
  
• Products that require UKCA/UK NI marking

For answers to questions such as:

• What is the CE mark?
• How much does CE marking cost?
• What products need CE marking?

And information on how to place the CE mark on your products.

Small or Micro Manufacturers often find it too costly to directly employ a PRRC, under MDR Article 15 this role can be outsourced to a company such as Cranage Veritas.