Design Services

FromBoyd Biomedical

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We provide design services for clients who need product and process development support for regulated devices and components.

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Program Management

We provide program management as part of our design services. This includes:

Design & Development Plan
Design Controls
Validation Master Plan
Project Management

Design Engineering

We provide design engineering as part of our design services. This includes:

Electrical Engineering
Mechanical Engineering
Human Factors Engineering
Industrial Design
Software Development

Prototype Engineering

We provide prototype engineering as part of our design services. This includes:

Alpha prototypes (looks like, may work like)
Beta Prototyping (looks like, works like)

Process Engineering

We provide process engineering as part of our design services. This includes:

Define product and process requirements
Specify and procure tooling and equipment
Process Verification & Validation (IQ, OQ, PQ)
Sustaining Engineering
Automation & Capacity Expansion
Cost Down Modeling

Quality & Regulatory Support

We provide quality and regulatory support as part of our design services. This includes:

Essential requirements and risk analysis
Design control documentation
Manufacturing documentation
Inspection Protocols and AQLs

Material Sourcing

We provide material sourcing support as part of our design services. This includes:

Advanced flexible materials
Chemicals
Excipients
Active Pharmaceutical Ingredients

Testing

We provide testing as part of our design services. This includes:

Tensile Strength, Peel Strength, Elongation, Seal Integrity, Leak, Dimensional Metrology
pH,Density, Viscosity, Titration, FTIR, Tensiometry, Endotoxin Testing, Shelf-life Studies
Third Party Testing