Software as a Medical Device (SaMD)
Software as a Medical Device (SaMD) is transforming the healthcare landscape, from mobile health apps to AI-driven diagnostics. These innovations deliver personalised care and improved outcomes — but also require rigorous regulatory alignment.
At Apotech, we keep pace with the evolving regulatory environment for SaMD. Our specialist consultants offer strategic and operational support to ensure your software product is fully compliant, safe, and effective.
Trusted by top-tier teams worldwide
Our SaMD Services
We provide tailored support for SaMD manufacturers, including:
- Pre-market regulatory strategy development
Intended Use, Risk Classification, Notified or Approved Body engagement, and Technical File structure. - Quality Management System (QMS) implementation
ISO 13485, ISO 14971, ISO 12207, and QMSR-compliant systems. - Regulatory submissions and approvals
Comprehensive assistance with technical documentation, submissions, and engagement with regulators. - Clinical Evaluation
Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), state-of-the-art analysis, literature review, risk management, PMCF. - Post-market surveillance and vigilance
Ongoing monitoring and reporting aligned with MDR, IVDR, and other global standards. - Training and education
Bespoke workshops and training modules tailored to your team and product lifecycle stage.
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…