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MEDICAL | FDA Compliance

Authentise software is being used as a core part of the FDA certification process.

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Our proven software validation process gives medical device manufacturers the confidence they need for the Quality Assurance process.

At Authentise we have the ability to arrange a highly integrated set of systems enabling customers to bring data and processes together, enabling quality control and, critically - FDA compliance.

FDA Approved - Authentise
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Now Medically Qualified!

Our first customers have achieved their 501(k) FDA clearance.

 

To help them accomplish this, Authentise is compliant with 21 CFR 820 and ISO 13485:2016.


Of course, Authentise's software development process follows FDA Guidance – General Principles of Software
Validation (GPSV) and ISO TR 80002-2:2017.


With our rigorous development processes and validation systems, our customers can step into their own certification journey with confidence.

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CORE NEW MEDICAL FEATURES

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Assemblies
Manage colour prints and assemblies easily to streamline your production of surgical models.

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Enhanced Quality Reporting
Produce the full master record from production related records.

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Certified Builds
Reproduce the same builds with the same layout, specimens and process over and over again.

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Delivering Clear Benefits

Read Ricoh's story and discover how Authentise have provided the core industrial engineering and workflow management within their production facility. 

Top 6 UNIQUE CAPABILITIES

Deep data connectivity
Use machine data for automation and detailed reporting

Additive focused features
Manage builds, materials and post processing with Authentise

Medical Compliance
Embark on your 501(k) programme with confidence.

Integrate into your IT
Infrastructure

REST API's to integrate with ERP, PLM & more.
SSO + Private Hosting/on-rem options.

World Leading Openness

+700 connections ensure we can connect your processes & tools.

Fully Configurable
Create your own fields, workflows, users and machines. Develop your own applets.

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"At Authentise we’re extremely proud of the efforts our customers have undertaken. In addition to providing a key backbone for the agile environment they need, the Authentise contextual data platform enables data, and processes to be brought together, enabling quality control and, critically, FDA compliance"

Andre Wegner - Authentise CEO

NEXT STEPS