Light to Insight

Support

Technical documentation

Our technical documentation allows you to register your customized system based on our reader very easily. The necessary support you need as private label manufacturer for registration of your product at local authorities in your target countries is given.

We work according to the Quality Management ISO 9001, ISO 13485 Standards and US FDA 21 CFR Part 820.

If you look for additional regulatory advice, DIALUNOX will be happy to assist. Our network of experienced consultants can help you accelarate your submission to the regulatory bodies.

Technical documentation
OEM support

Ongoing trainings & maintenance

As part of our customizing service, we offer

  • Free remote training helping to optimize your lateral flow reader settings for best interpretation of your test bands
  • Constant troubleshooting to resolve any technical issues
  • Product development support from a dedicated Project Manager and a skilled interdisciplinary team
  • Ongoing maintenance, assistance and information about SW updates
  • Expert lateral flow development webinars and workshops that provide valuable insights and hands-on orientation

Regulatory advice

If your company does not possess the required know-how in the regulatory field, you are in good hands with DIALUNOX advisory service. Our experienced consultants with both regulatory and scientific background will help you accelerate your submission to IVDR and FDA regulatory bodies ensuring its success and helping identify the right documentation strategy. If need be, they can also serve as a contact point with regulatory authorities and prepare your QM system for audits.

This is what we offer in a nutshell:

  • Quality management: check and improve your internal processes
  • Market entry and risk management: create a concept for the market entry of your innovative medical product
  • Technical documentation: prepare the registration or approval of your medical device in the individual target markets.

Book this service via DIALUNOX and ensure a smooth and fast  processes for your submission.

regulatory advice

Download the latest software and manuals for your reader.

Frequently Asked Questions

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