Quality

QUALITY AND REGULATORY

We value and understand the importance of using dependable suppliers for both the product supplied and the service provided. This is why everything we do at ARROTEK is carried out in accordance with our ISO 13485:2003 & EN ISO 13485:2012 accredited quality management system. We are FDA registered & audited and currently supplying finished sterile product into the US.

Regulatory:

 

Our team includes experts in medical device regulation who can guide you through CE marking, FDA submission and other regulatory needs for your product.

Our services include:

  • Process Validations
  • Sterilisation Validation
  • Age testing for shelf life
  • Transportation Testing
  • Bench testing of transport and aging units
  • Clinical language verification for instructions for use
  • Testing to ISO standards
  • Label design
  • File compilation and submissions for regulatory approvals.

If you would like to provide you with a regulatory evaluation, contact us now at sales@arrotek.com with questions, or phone us at +353 71 91 15111.