SoftwareCPR

SoftwareCPR specializes in regulatory compliance consulting and training for medical device manufacturers and healthcare technology companies. The firm focuses on helping organizations navigate FDA requirements, international standards like IEC 62304 and ISO 13485, and compliance frameworks including 21 CFR Part 11 and medical device cybersecurity standards.

The company provides consulting services for regulatory compliance, training courses on quality management systems and software lifecycle processes, and maintains an extensive library of resources including FDA recall analyses, regulatory updates, and technical guidance documents. Their content covers topics from GRASP software design patterns to diffusion of responsibility in quality systems, demonstrating deep technical and regulatory knowledge.

SoftwareCPR tracks FDA software recalls systematically, publishing detailed analyses of enforcement actions and software-related device failures. They offer both US-based and international training, including courses in locations like Kuala Lumpur for medical device manufacturers seeking to meet FDA and EU regulatory expectations.

Choose SoftwareCPR when regulatory compliance expertise is the primary need rather than software development services. Their systematic approach to FDA requirements and detailed knowledge of medical device software standards makes them valuable for companies facing audits, preparing submissions, or establishing compliant processes.

Expect educational consulting focused on helping internal teams understand and implement regulatory requirements correctly. Their recall tracking and analysis provides practical insights into common compliance pitfalls in medical device software.

SoftwareCPR operates exclusively in the medical device and regulated healthcare technology space, focusing on FDA compliance requirements for software-controlled medical devices and Software as a Medical Device (SaMD). Their expertise spans the regulatory landscape including FDA guidance documents, EU Medical Device Regulation requirements, and Health Canada standards.

The firm maintains specialized knowledge in medical device quality systems (21 CFR 820), software lifecycle management (IEC 62304), and medical device cybersecurity. Their recall analysis service provides ongoing surveillance of FDA enforcement actions related to software issues, offering practical insights into compliance requirements.

Medical device companies and healthcare technology firms developing FDA-regulated software products who need specialized regulatory guidance. Best suited for organizations at early to mid-stages of regulatory maturity who are establishing or improving their quality management systems and software development lifecycle processes to meet FDA and international standards.