Contract Statistical Services
WHAT WE OFFER...
It is important to understand the criticality of properly analyzing engineering data. Engineered Datalytics guides you in the valid application of statistical tools in analysis areas such as design exploration, design verification, manufacturing process validation, design validation, on-going quality control, and data trending. The guidance provided will help to simply your efforts, reduce your analysis time, facilitate the formulation of accurate and appropriate conclusions, and will ensure your teams meets the expectations of the FDA.
US Code of Federal Regulation (Medical Device): 21 CFR 820.250
- Where appropriate, each manufacture shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capabilitiy and product characteristics.
- Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacture shall establish and maintain procedures to ensure that sampling methods are adequate for thier intended use and to ensure when changes occur the sampling plans are reviewed. These activities shall be documented.
SERVICES INCLUDE BUT ARE NOT LIMITED TO...
- Graphical Analysis
- Distirbtuion Analysis
- Hypothesis Testing
- Tolerance Analysis Percent Conformance Analysis
- Reliability Analysis
- Process Capabiltiy Analysis
- Trending Analysis
- DOE Development
- Lot Acceptance Sampling
- Equivalence Testing