Our team of quality software experts have over 20 years of individual experience in medical device regulatory compliance for the US and globally (Canada, China, EU, Japan, etc.). Our team is kept up to date with the current state of affairs and are able to help you comply with current expectations and future changes.
Standard Procedures and Templates
Save time and money by purchasing our standard software development procedures and templates covering various aspects of FDA guidance such as validation, medical device software, software as a medical device, cyber security, IEC 62304 and IEC 62366.
Customized Procedures and Templates
Tailor existing procedures and templates to meet the specific needs of your business such as maintaining consistency, complementing exiting procedures, adapting to the company culture, etc.
Design History File Creation
Keep your team focused on your core competencies while we prepare for your regulatory submission (architecture, requirements, design documents, tractability, etc.)
Reduce the business risks of being non-compliant by scheduling a thorough audit, gap and risk assessment of your current processes (software development, validation, privacy and security such as GDPR, CCPA, etc.)
Design History File Remediation
Bring existing, legacy or acquired products up to current regulatory standards
by remediation design history files.
Software Tool Validation
Reduce overhead by outsourcing software tool validation for third-party and custom in-house tools with our simplified, yet effective process.