Software as a Medical Device, AI as a Medical Device and Machine Learning

Ensure complete regulatory compliance in all your artificial intelligence and software-based MedTech devices.

Overcoming regulatory hurdles in high-tech MedTech devices

Trust Apotech for complete compliance

At Apotech, we understand the growing challenges global health systems face due to rising demands and limited capacity. 

To tackle these issues head-on, we’ve noticed a shift towards the need for technological solutions, especially in the areas of software as a medical device (SaMD) and artificial intelligence as a medical device (AIaMD). 

SaMD is designed to cover medical software created for diagnostic, monitoring or treatment purposes, excluding hardware components. Whereas AIaMD involves using software that harnesses AI algorithms for clinical decision-making, predictive analytics and data-driven insights.

Through our team’s expertise and experience, we can help MedTech manufacturers within this area reach markets around the globe with complete compliance and expedited entry. 


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Software as a Medical Device (SaMD)

Over recent years, SaMD has rapidly evolved thanks to various advances in technology. From mobile health apps to AI-driven diagnostic tools, SaMD has expanded its scope, enabling personalised care and improved clinical outcomes. 

At Apotech, we have remained proactive in keeping up to date with evolving regulations and initiatives surrounding medical devices as software. Through this commitment, we have ensured that our practices align with the latest standards and requirements.

We can support you in the following areas of SaMD:

  • Pre-market regulatory strategy development – Intended Use, Risk Classification, Notified or Approved Body Engagement, Technical File Design 
  • Quality Management System (QMS) implementation – ISO 13485, ISO 14971, ISO 12207, QMSR 
  • Regulatory submissions and approvals
  • Clinical Evaluation – CEP, CEP, State-of-the-art, Literature Review, Risk Management, PMCF
  • Post-market surveillance and vigilance
  • Training and education 

AI as a Medical Device (AIaMD) & Machine Learning (ML)

The introduction of AI into the market has seen it gain traction within the UK, EU, USA and globally. This, coupled with the EU AI Proposal, MHRA Change Programme and FDA Proposed Regulatory Framework for Modifications to AI/Machine Learning (ML) Based SaMD coming into force, means there's now a clear urgency to enhance regulatory frameworks. 

As medical devices continue to incorporate AI, new regulations set by regulators like the MDR, IVDR and the FDA require AI-driven medical devices to not only comply with state-of-the-art requirements but also provide objective evidence for repeatability and reliability. 

The beneficial impacts of AI and machine learning are far-reaching and offer great potential. That’s why, at Apotech, we stay up to date with any relevant regulatory developments, to help bring your device to market. 

Here’s how we can support you: 

  • Pre-market regulatory strategy development – Intended Use, Risk Classification, Notified/Approved Body Engagement, Technical File Design
  • Quality Management System (QMS) implementation – ISO 13485, ISO 14971, ISO/IEC 42001, QMSR, IEC 62304, IEC 82304-1, MHRA, FDA and Health Canada agreed Good Machine Learning Practice (GMLP)
  • Regulatory submissions and approvals
  • Clinical evaluation – CEP, CEP, literature review, risk management, PMCF
  • Post-market surveillance and vigilance
  • Training and education

IEC 62304

The IEC 62304 provides a framework for the software life cycle processes used in the development and maintenance of medical device software. 

Compliance with IEC 62304 is essential for medical device manufacturers to demonstrate the safety, reliability and regulatory compliance of their software products. Our team at Apotech can support your adherence to this standard to help ensure that your medical device software meets the quality and safety requirements required throughout its life cycle. 

Excited to work together on your next project?
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Our range of SaMD, AI as a Medical Device and Machine Learning Services

At Apotech, we are well-versed in the complexities that introducing cutting-edge MedTech solutions to new markets can bring. 

That’s why we’ve designed our wide array of services to offer you strategic insights and hands-on support, ensuring not only regulatory approval but also long-term commercial success.

Why choose Apotech for SaMD, AI as a Medical Device and Machine Learning?

With over fifty per cent of our MedTech portfolio comprising AI or software solutions, we've collaborated with numerous MedTech companies over the past few years, ensuring compliance and implementing quality assurance practices for their products. 

Through our specialised methodology, we can now navigate these agile entities through our regulated environment, facilitating compliance, mitigating risks and expediting entry into markets like the EU, USA and UK.

Featured case studies

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…

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