ISO 62304: Medical Device Software Lifecycle Processes  

We design and implement lifecycle processes for medical device software, ensuring alignment with ISO 62304 to support software safety, reliability, and compliance with regulatory expectations for technology-driven solutions. 

 

ISO 14971: Risk Management for Medical Device Software  

Our team conducts comprehensive software risk management processes to mitigate risks associated with patient safety, product performance, and system reliability, adhering to ISO 14971. 

 

GAMP 5: Good Automated Manufacturing Practices  

We apply GAMP 5 to validate computerized systems and software, balancing regulatory expectations with streamlined technology implementation and operational efficiency. 

 

21 CFR Part 820: Quality System Regulation (QSR)  

We support the development and implementation of compliant quality systems for medical device software and technology, ensuring adherence to FDA requirements for design, production, and postmarket activities. 

 

21 CFR Part 11: Electronic Records and Signatures  

We help clients establish and maintain secure software systems for electronic records and signatures in compliance with FDA regulations, ensuring data integrity and traceability. 
 

21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

We guide life sciences companies in meeting FDA 21 CFR Part 211 requirements by providing expertise in computer system validation, data integrity, and quality system documentation. Our services ensure that software and computerized systems used in manufacturing, testing, and record-keeping comply with regulatory expectations and are fully supported with audit-ready documentation.

​

FDA Software Guidance: Content of Premarket Submissions for Device Software Functions
We assist organizations in preparing compliant software documentation for FDA submissions, addressing key elements such as design, risk management, verification, validation, and cybersecurity to meet regulatory expectations.

CAP & CLIA Laboratory Compliance  

Our expertise includes guiding laboratories in implementing software solutions to meet CAP and CLIA requirements, ensuring accreditation while improving operational and technological efficiency. 

 

FDA Cybersecurity Guidance  

We ensure medical device software complies with FDA premarket and postmarket cybersecurity guidance, including software-specific risk assessments, vulnerability testing, and security protocols to mitigate threats. 

 

EU MDR/IVDR Compliance  

We assist companies in aligning with EU MDR and IVDR by addressing software compliance, validation, and risk management to meet European regulatory standards for medical device technology.

​

AI/ML Guidance 

We help life sciences companies align with FDA premarket cybersecurity guidance by advising on risk assessments, threat modeling, and security controls required for regulatory submissions. Our services ensure that cybersecurity documentation, including Software Bill of Materials (SBOM), vulnerability management, and post-market plans, is complete, accurate, and audit-ready for FDA review. 

​