Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA
Introduction
Deciphex
Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharmaceutical companies for handling high volume drug safety pathology studies. They provide a complete GLP-compliant workflow with integrated AI screening capabilities.
Standards & Tools
- EU-IVDR 2017-746
- ISO 13485
- ISO 14971
- IEC 62366
- GDPR
- Word Excel, Powerpoint
Scope of work
As a growing MedTech company, we face many complicated challenges to understand how to bring our digital pathology solutions to various markets. Apotech has been an outstanding support to us with scoping requirements for various initiatives, including AI requirements for medical software tools, GLP and other projects. Their ability to actively listen to our requirements and find the exact type of consultants for our needs has been key for us. Apotech has an impressive portfolio of consultants ranging in expertise including software, regulatory, quality, validation and biomedical. For a growing MedTech company, controlling cost and timelines are vital. Apotech has always been flexible and very understanding of constraints facing startups, and they make it easy to discuss and agree price plans for their services.
We have used Apotech services for the past 2 years and we look forward to working with them as our company grows and develops. Apotech always delivers for us!
Key numbers
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