What Are FDA & QA Medical Solutions?
DFM & QA involve methodologies designed to optimize medical devices for manufacturability while ensuring they meet the highest quality standards. This process includes detailed planning to ensure devices can be manufactured reliably and achieve regulatory approval efficiently.
Our FDA & QA Process
- Design & Development: We design devices with manufacturability in mind, optimizing each design for cost-effective production without compromising on quality.
- Prototyping & Testing: We develop prototypes and conduct extensive testing to evaluate their functionality and safety. While we prepare the groundwork for compliance, clinical testing responsibilities remain with our clients.
- Regulatory Compliance & Approvals: Our team's deep familiarity with global medical device regulations enables us to efficiently navigate the certification process, ensuring all necessary documentation and pre-clinical testing align with international standards.
