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Useful Information and FAQ's



Helping You Navigate Regulatory Affairs and Global Certifications Requirements


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For the latest company news, and useful information on global market access and product certification.
Including information on CE Marking, NRTL Certification, FDA 510(k) Premarket Notifications, UKCA/ UKNI Marking and more.



NRTL Certification Information



Useful Information and FAQ's Relating to the NRTL Certification Process





For information and answers to questions such as:

  • How does the NRTL Certification work?
  • Who is responsible for NRTL Certification?
  • What products need NRTL Certification?


Find out more by clicking the button below.


Read About NRTL

FDA 510 (k) Information



Useful Information and FAQ's for Medical Device Market Access to the US.





For answers to questions such as:

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

Read About FDA 510(k) Process

UKCA / UKNI Information



Useful Information Relating to the new UKCA / UKNI Marks





For information on:

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

Find Out About UKCA and UKNI Marks

Information on the CE Mark Process



CE Mark Guidance, FAQ's and Notified Body Assistance





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.


CE Mark Frequently Asked Questions

MDR Article 15 - Person Responsible for Regulatory Compliance



Useful Information Regarding the PRRC Process for Small Manufacturers





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.


Find Out How Article 15 Works

IECEE CB Scheme & LTR Service



Useful Information & FAQ's Regarding the CB Certification





For information on:

  • The CB Certification process
  • The Countries covered by CB Certification
  • Third-Party CB Testing Engineer Services (LTR)
  • Products that require CB Certification.

How the CB Certification Process Works


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Cranage Veritas



Info@cranage.ie

Cranage Veritas Limited
Suite 301 Airport House
Shannon Free Zone
Shannon
County Clare
Ireland
V14N578