Reliable and safe products and services throughout the supply chain

ISO 13485 Certification

Our experienced team will help connect you with relevant regulatory bodies for a smooth Medical Device approval process
Legal access to markets for products is essential for manufacturers of medical devices. ISO 13485 is often required by National and International regulations as part of the approval process for medical devices.

Our services include

• ISO 13485:2016 Certification for medical devices in all classes of:
  • I
  • Is
  • Im
  • IIa
  • IIb
  • III

• Pre-Audit in accordance with ISO 13485:2016

CE Marking

Our services include

• Pre-Assessment and Gap-Assessment Services, especially useful for first-time manufacturers designing a product intended for certification under the MDD/MDR
• Technical documentation/file or design dossier assessment/review for CE marking of Medical Devices