Regulatory Affairs
We empower clients to bring their IVD diagnostic kits to market with confidence and compliance.
Navigating the regulatory landscape can be challenging, but our expertise makes it seamless. We stay updated with regulatory changes and ensure that all our documentation and processes support our clients’ regulatory submissions.
Our Regulatory Affairs department is committed to guiding our clients through the regulatory processes of both the EU and US markets, by providing support in CE marking or the FDA submission process.
WHAT WE DELIVER
Regulatory Compliance Assurance
Ensuring compliance with relevant regulations such as the FDA in the US, the CE directive in the EU, and other national or international regulatory frameworks.
Risk Assessment
Conducting thorough evaluations of risks associated with IVD diagnostic kits, including patient health risks, result accuracy, and user safety.
Process Validation
Validating manufacturing, assembly, and quality control processes to ensure reliability and reproducibility of IVD kit results.
Clinical Study Support
Collaborating with clients to monitor and participate in clinical studies to assess IVD kit performance, including sensitivity, specificity, and diagnostic accuracy
Labeling and Documentation
Ensuring compliance with relevant regulations such as the FDA in the US, the CE directive in the EU, and other national or international regulatory frameworks.
Quality Verification
Establishing quality control systems to monitor IVD kit manufacturing, ensuring compliance with specifications and detecting potential quality issues.
Change Management
Managing changes throughout the IVD kit lifecycle, documenting changes, assessing their regulatory impact, and implementing them appropriately.
Regulatory Authorities Interaction
Engaging with competent regulatory authorities to obtain necessary approvals and maintain transparent communication regarding regulatory aspects of the kit.
