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
Guidance on regulatory requirements for medical software, including artificial intelligence & diagnostics
Scoping regulatory frameworks to enter the GCC countries
Scoping regulatory frameworks to enter the US as an LDT, through the CLIA process
IVDR strategy for CE Marking and UKCA
Assist with local notified bodies
Scoping ROW markets, including US FDA guidelines, 510(k) / De Novo
Scoping GLP framework for laboratories in the UK and development of SOPs to be managed within the QMS
Key numbers
Team
4 consultants
Location
Global
Length
12+ months
Type
Work package