Expert Software Quality Services for Cutting-Edge Medical Devices
SOFTWARE
QUALITY
We understand software's critical role in the functionality and reliability of medical devices, which is why we employ a rigorous, quality-centric approach to every project. Our commitment to enhancing the quality of medical software goes beyond mere compliance.
At the heart of our mission lies a dedication to exceeding standards and driving innovation in healthcare technology. With an unwavering focus on precision and excellence, our expert team provides customized software quality support tailored to the unique needs of each medical device.
MEDICAL DEVICE
VALIDATION IEC62304
Our team provides seamless solutions to bring your innovative ideas to life with confidence in meeting the standard.
Partner with us for success in the medical device industry.
COMPUTER SYSTEM
VALIDATION (CSV)
With a focus on ensuring that your systems operate as intended and meet regulatory requirements, we'll help you navigate the complex world of GxP validation.
SUPPORT
OUR
We work with you across all components of Software Quality from creation to day-day administration.
Data Integrity
Assessing risk to data integrity and making recommendations to ensure data accuracy and consistency across a system's lifecycle.
Risk Management
Assessing system risks and providing recommendations for a risk-based approach to validation activities.
Software V&V
Providing support with validation lifecycle activities to prove that your system works in its intended environment​.
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Gap Analysis
Conducting gap analyses of your systems against regulatory requirements, with recommendations on how to address gaps.
CLOUD VALIDATION
(IaaS, PaaS, SaaS)
Validation Support of cloud-based systems, ensuring compliance to International regulations.
21 CFR Part 11 Compliance
Provide guidance in ensuring your electronic records and signatures are considered to be trustworthy and equivalent to paper records.
Lifecycle Documentation
We work with you to author validation documents. From Defining requirements, To providing templates, quality reviewing and remediation.
Configuration Management
Working with you to Define strategies for handling changes systematically so that a system maintains its integrity over time.
SOFTWARE SUPPLIER AUDITS
Carrying out audits on vendors of software and systems and providing documentation to support your validation strategy and demonstrate regulatory compliance.
Validation Strategy & Management
Supporting you in the development of compliant approach's to your computer system validation.
Spreadsheet Validation
Verifying the reliability of your spreadsheet and its output for its intended use.