Software Quality Management System
Quality Management System (QMS) for Medical Device Software
At Gener8, we specialize in building, enhancing, and optimizing Quality Management Systems (QMS) to ensure regulatory compliance, efficiency, and audit readiness for medical, biotech, and life sciences software development.
Comprehensive QMS Solutions
A well-structured QMS is essential for FDA approval and ISO certification. Our services help organizations implement and refine software-specific processes to meet:
✔ ISO 13485, FDA 21 CFR Part 820, and IEC 62304 compliance requirements
✔ Risk-based quality controls to ensure ongoing regulatory adherence
✔ Streamlined workflows and process optimization for greater efficiency
Proven Approach
Proven Methodology
Proven Performance
Build Your Own Software QMS
Many organizations have a general QMS but lack software-specific processes—this is where we excel. At Gener8, we help companies:
✔ Integrate software-focused procedures into their existing QMS
✔ Develop regulatory-compliant templates and documentation
✔ Review software code to ensure compliance with FDA, IEC 62304,
and ISO 13485
Whether you need to upgrade your current QMS or build a new system from scratch, we provide expert guidance to meet new and evolving regulatory standards.
Regulatory Assessments & Compliance Services
Ensure your Quality Management System (QMS) and development processes are ready for regulatory review.
Our assessment offerings are designed to help you identify and resolve gaps, meet compliance standards,
and approach submissions with confidence.
Pre-Submission Reviews & Compliance Assessments
Before engaging with regulatory bodies like the FDA, it’s critical to confirm that your QMS meets all necessary expectations. Our comprehensive assessments include:
✔ Review of SOPs, development processes, and documentation
✔ Evaluation of software validation, risk management, and traceability
✔ Audit readiness and alignment with applicable regulatory standards
We provide detailed compliance reports with actionable recommendations to ensure you’re fully prepared for submission.
Software Tool Validation for Regulatory Compliance
Development tools must be validated to comply with regulatory requirements. We offer:
✔ Validation of software tools used in development and testing
✔ Creation of supporting documentation for FDA and ISO audits
✔ Functional verification to demonstrate regulatory compliance
FDA Readiness Assessment
Achieving FDA approval requires a fully compliant QMS and a well-documented submission process. Our FDA Readiness Assessment provides:
✔ Comprehensive review of quality systems and design history documentation
✔ Gap analysis against IEC 62304 and FDA Cybersecurity Guidance
✔ A structured roadmap to address compliance issues and optimize submission readiness
Ideal for:
✔ First-time medical device software developers
✔ Devices adding networked functionality
✔ RUO (Research Use Only) to medical device transitions
✔ Companies seeking independent submission readiness reviews
Specialized Software Services
At Gener8, we provide tailored software solutions designed for the unique needs of medical devices, life sciences, and biotech industries.
Whether you’re developing a standalone digital health application or embedded software for laboratory instruments, our expertise ensures a seamless
path from concept to regulatory approval.
Instrument Software
SaMD
(Software as a Medical Device)
Cybersecurity
Cloud Solutions
Verification and Validation
QMS
(Quality Management System)
Browse Software Case Studies
Thousands of projects completed.
We’re proud to serve the Biotech, Medical, and Industrial markets.