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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
Frame 1000005946

Scope of work

Done

Guidance on regulatory requirements for medical software, including artificial intelligence & diagnostics

Done

Scoping regulatory frameworks to enter the GCC countries

Done

Scoping regulatory frameworks to enter the US as an LDT, through the CLIA process

Done

IVDR strategy for CE Marking and UKCA

Done

Assist with local notified bodies

Done

Scoping ROW markets, including US FDA guidelines, 510(k) / De Novo

Done

Scoping GLP framework for laboratories in the UK and development of SOPs to be managed within the QMS

Have a project in mind_ Let’s work together!
Brian - Director QA RA

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

Management

Team

4 consultants

Charity

Location

Global

Combo Chart

Length

12+ months

WeChat

Type

Work package

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Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.