Software Quality Assurance
Empower Your Medical Device Software for Success with Our Expert Quality Assurance Services and Collaborative Approach.
Explore how our support can elevate your software goals and needs.
At iDE8 , we understand the importance of clear and precise terminology in the medical device industry. That's why it's essential to understand the differences between Computer Software Validation (CSV), Software Quality Assurance (SQA), and Software as a Medical Device (SaMD).
CSV involves validating computer-based software to ensure it meets industry standards and regulatory requirements.
SQA focuses on internal quality control processes and procedures to guarantee software and firmware meet customer expectations and are fit for purpose before release. Meanwhile, SaMD refers to software that operates as a medical device and requires specific development, validation, and risk control approaches.
We want to ensure our clients are equipped with the right knowledge and understanding to navigate the ever-evolving medical device industry.
Contact us today to learn more about our expertise in CSV, SQA, and SaMD, and how we can help you achieve greater success.
Medical Device Validation to IEC 62304
Our knowledgeable team provides seamless solutions to bring your innovative ideas to life with confidence in meeting IEC 62304 standards..
Partner with us for success in the medical device industry.
Computer System Validation
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.
Our Support Services
We work with you across all components of SQA creation to day-day administration.
Assessing risk to data integrity and making recommendations to ensure data accuracy and consistency across a system's lifecycle.
Assessing system risks and providing recommendations for a risk-based approach to validation activities.
Providing support with validation lifecycle activities to prove that your system works in its intended environment.
Conducting gap analyses of your systems against regulatory requirements, with recommendations on how to address gaps.
(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.
We work with you to author validation documents. From Defining requirements, To providing templates, quality reviewing and remediation.
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.
Verifying the reliability of your spreadsheet and its output for its intended use.