Want to halve your medical device complaints closure time?

UDI-based smartphone App provides fast and accurate complaint data with direct connection to your customers for faster closure and new regulatory compliance.

Faster, Easier and Accurate as 1, 2, 3.

1. Scan UDI

Scan the Unique Device Identifier (UDI) barcode - instantly identifying the manufacturer, device model and serial / batch.

2. Report Complaint

Register your hospital, and report issues via interactive form, attach photos, videos, or audios, and communicate with the support team.

3. Get Quicker Resolution

Track progress and get timely updates for a fast resolution.

Manage complaints, faster, easier and more accurately.

UDILink enables easy, instant and accurate user reporting of medical device complaints and feedback to manufacturers as required by the FDA and similar authorities.

Discover the ease of UDI with UDILINK

1. Scan UDI on medical device.

Don't have a medical device in front of you? Try with our demo UDI here.

2. Record and describe problem, and upload to manufacturer.

3. Quicker communications and updates

What you can expect from UDILINK?


Benefits for Manufacturers

Obtain more and higher quality postmarket feedback, improving product safety, performance.

  • Improve ISO13485 / 21CFR820 post-market feedback compliance given increasing regulatory focus on this area; include platform in PMS Plan and data in PMCF / PSUR.
  • Obtain timely feedback that is well described, complete, accurate and supported by actionable evidence.
  • Reduce call centre and support staff load from chasing customers with phone calls for details and follow up.
  • Reduce multiple Field Engineer callouts to identify the device, get the full story from witnesses and then still often fail to define or reproduce problem.

Benefits for Users

Quick efficient accurate complaint and feedback reporting platform for users - field engineers, hospital nurses, unit managers, technicians, service staff, consumers.

  • Identify full device details with one snapshotusing the mandated UDI barcode.
  • Communication Skills to getting in touchEasily capture and upload photo and video evidenceat the time of the problem.
  • Capture evidence of malfunction which maynot be easily reproducible later.
  • Guided complaint description – ensures key descriptive,risk and urgency information avoiding multiple inquiries fordetails, phone calls, representative visits.

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Scan demo UDI QR code

Scan the UDI code which is located on the problematic medical device or use the sample code as below