Quality Assurance & Regulatory Affairs
Quality assurance and regulatory affairs are essential pillars in the development of safe, effective, and compliant medical devices.
At Critical Software, we help manufacturers navigate the complex landscape of global regulations, ensuring that their products meet the highest standards of safety and performance.
Design Control & Documentation
We support clients in implementing robust design control processes that ensure traceability from concept to deployment. This includes managing design inputs and outputs, verification and validation activities, and changing control procedures. Our documentation practices are aligned with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and MDR, enabling smooth audits and regulatory submissions.
Regulatory Affairs & Compliance
Bringing a medical device to market requires navigating a maze of regulatory requirements. We assist clients in achieving compliance with international standards such as ISO 13485, IEC 60601 series, IEC 62304, and 21 CFR Subchapter H. Our team has hands-on experience preparing technical files, supporting audits, and ensuring post-market surveillance obligations are met. We also bring expertise in GDPR and TÜV certification, helping clients address data protection and quality assurance in regulated environments.
Certification Support
We provide end-to-end support for certification, including the production of essential software artefacts and documentation. This covers requirements specifications, design documentation, code reviews, test plans and reports, configuration management files, and final certification packages. Our structured approach ensures that all deliverables are audit-ready and aligned with the expectations of notified bodies and regulatory agencies.
Training & Knowledge Transfer
Our training programs are tailored to the professional background of each audience, offering practical insights into regulatory frameworks and implementation strategies. These sessions help manufacturers understand the scope and impact of standards, streamline their compliance efforts, and build internal capabilities for long-term success.
Whether you're launching a new product or updating an existing one, our quality assurance and regulatory affairs services ensure that your device is safe, compliant, and ready for the market.
