IEC 62304: Software Lifecycle Compliance
IEC 62304 sets out the software lifecycle requirements for medical device software — from development to decommissioning. Compliance is essential to demonstrate software safety, reliability, and regulatory alignment.
At Apotech, we guide manufacturers through the full IEC 62304 lifecycle, helping ensure that your device software meets the stringent quality and safety requirements of global regulators.
Trusted by top-tier teams worldwide
Our IEC 62304 Services
- Gap analysis and compliance planning
Evaluate existing processes and documentation against IEC 62304 requirements. - Lifecycle process definition
Structure and document software lifecycle processes to meet regulatory expectations. - Verification and validation support
Develop robust testing and validation protocols aligned with your software risk class. - Technical documentation preparation
Comprehensive documentation including software architecture, hazard analysis, unit and integration testing records. - QMS alignment
Integration of IEC 62304 within your ISO 13485 or broader quality system.
- Training and workshops
Equip your team with a working understanding of IEC 62304 principles and expectations.
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…