At this stage, your medical device product receives regulatory approval, we launch production, and Biomerics continues to assist you with post-launch quality and regulatory activities.
High-level outputs
- Determine medical device reporting (MDR) methodology to handle post-launch issues
- Obtain management approval to release product to market
- Begin production
- Post-launch, submit reports to regulatory bodies as required
- Review plan for continuous improvement
- Handle CAPA (corrective action preventative action) feedback, if any, post-launch, following FDA requirements
Results
The Product Design management team approves the product for release to market. Once the product clears either FDA or EU governing bodies, you are ready to launch. The Product Design team signs off on the MDR methodology and plan for continuous improvement prior to launch.
Tools
We use a detailed process—following established standard operating procedures and ISO requirements—to file for and receive regulatory approval and achieve management approval to release the product to market. After your product is in production, Biomerics continues to support you post-launch.
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