Validation & Design Transfer Phase In this phase the product is tested by a team outside the development team such as beta customers. This is also where pre-production builds take place and the production process is finalized for launch. Documentation is buttoned up and released in it's final state. Baymar can support you in the following areas of the validation and design transfer phase. Click the "+" symbol for more details.
Engineering Services
Design for Manufacturability

Design for Assembly

Cost Reduction

Package Design

Labeling

Injection Molded Plastics

Reliability Testing & Improvements

Design Optimization

Process Optimization

Test Method Validation

Writing and Execution of Protocols

Design Change Management

Stability Testing

Material Compatibility Testing

Safety / EMC Testing Support

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Scientific Services
Scientific Study Design

Test Method Validation

Writing and Execution of Protocols

Design Change Management

Stability Testing

Assay Development

Reagent Development & Formulations

Quality Control Requirements

Clinical / Technical Literature

Scientific SOP Development

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Design Transfer Services
Assembly & Test Fixtures

Inspection Fixtures

Manufacturing Setup

Service Parts & Assemblies

Field Service Manual & Procedures

In-Process Inspection & Testing Fixtures

Equipment Validation

Manufacturing Work Instructions

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Documentation Services
Design History File (DHF) Support

Risk Management

Device Master Record (DMR) Creation

Device History Record (DHR) / Traveler Creation

Traceability Matrix Updates

Finalize Bill of Materials

Incoming Material / Component Inspection Procedures

In-Process Inspection & Testing Procedures

Final Acceptance Testing Procedures

Engineering Drawings

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Project Management Services
Configuration Control

Agile Project Management

Vendor Management & Collaboration

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