The benefits of working with an ISO13485 Certified Label Manufacturer

Medical Device Labels

13 Jan The benefits of working with an ISO13485 Certified Label Manufacturer

For manufacturers of medical devices, quality is of utmost importance. It is imperative that these medical device manufacturers are dealing with suppliers that have a comprehensive quality management system in place. ISO 13485 accreditation displays international credibility and commitment to quality.

One of the most common reasons for medical recalls is labelling errors (As posted on the Medical Device Academy Website) . This highlights further the need to work with a medical label manufacturer with the accreditation and experience in the market you can trust.

An ISO13485 accredited label manufacturer will benefit their customers as they will:

  • Meet regulatory requirements
  • Exceed customer expectations
  • Aid in monitoring the effectiveness of your supply chain
  • Increase the probability of manufacturing safe and effective labelling solutions
  • Consider risks associated with processes used and product supplied


ISO 13485 accreditation ensures a company’s quality management system is operating at the highest level. The system puts procedures and structures in place to mitigate against risk and ensures you receive the highest quality product every time. ISO 13485 certified label manufacturers also offer medical companies the following benefits:

  • Harmonization in the level of systems and controls offering increased ability to respond to customer requirements efficiently and effectively
  • Full traceability on raw materials
  • A risk-based approach to the product and process to enhance quality assurance
  • With improved systems and controls resulting reduced fallout and reduced operational costs ultimately giving cost savings to the Customer
  • Peace of mind / confidence in us as a supplier that we can deliver quality product


In addition to our ISO 13485 accreditation check out the additional services we supply our customers with here.

Medical Device LabelsSystem Label is one of the only ISO13485 certified label manufacturers in Europe. Contact us today and one of our friendly team would be delighted to discuss your requirements. Email: or call the office on: +353 (0)90 6630 900 , +44 (0)1438 791750.