Product Design + Prototyping

intellectual property generation

• industrial design

• mold design

• rapid prototyping (machining, 3D printing, injection molding)

• feasibility testing

• test method development

• label design

• IFU authoring

• design inputs generation

Quality

risk management

• design controls management

• QC procedures

• Quality System Remediation, FDA / Notified Body Audit Responses/ submissions

Verification + Validation

design verification

• design validation

• ISO 80369 connectors validation

• process validation

• benchmarking

Project Management

we can fully manage your
project, no matter how small
or large, from start to commercialization.

Product Design +

Prototyping

intellectual property generation

• industrial design

• mold design

• rapid prototyping (machining,

• feasibility testing

• test method development

• label design

• IFU authoring

• design inputs generation

Quality

risk management

• design controls management

• QC procedures

• Quality System Remediation,  FDA / Notified Body Audit  Responses/ submissions

Verification + Validation

design verification

• design validation

• ISO 80369 connectors validation

• process validation

• benchmarking

Project Management

we can fully manage your project, no matter how small or large, from start to commercialization.