THERMOCYCLER
A hand-held, portable thermocycler providing real-time detection for various assays. Used as an on-the-go lab in critical environments, this device pairs with a mobile application allowing users to customize parameters.
How PSI Helped:
- Conducted gap analysis providing insight as to what documentation and development was needed to satisfy FDA requirements.
- Provided consulting services regarding Class II medical device regulatory requirements
- Created a customized medical device documentation package and worked hand-in-hand with client’s team to complete necessary regulatory documentation
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