A Seisa Medical

Company

  © 2019 by Burpee MedSystems

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OUR DESIGN PROCESS

We utilize our capabilities to pull together any combination of design, prototyping, simulation, and testing to meet your goals.

We Design For:

Performance

Manufacturability

Time-to-Market

Cost Effectiveness

Integrated Development

Having design, prototyping, simulation, and testing under one roof allows us to employ an integrated development approach to optimize designs.

Customized Project Management

We provide project management tailored to the needs of the customer. Some require management on a small section of the project whereas some require full project management to drive the project forward.

Full Design Controls

 We can provide a full design control package in-line with FDA guidance. The design controls will bring your product through concept feasibility, development, and validation phases resulting in a complete design history file transferrable to the customer. Throughout the design controls we will lead design reviews, hazard identification, and risk analysis.

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CONCEPT

From the start of your design our engineering team can offer guidance and support. Through the lens of our experience we'll address critical device requirements as they pertain to your products clinical need and generate a Concept that is designed for excellence.

 

PROTOTYPE + REFINEMENT

Our integrated team of development engineers can quickly prototype and test new design concepts, thereby accelerating your project timeline.  We have a proven knack for quickly getting to the key challenges of new designs.

 

VERIFICATION + VALIDATION

When your device is ready for Clinical/Preclinical trials, Burpee Medsystems can define and execute necessary verification tests and trials using in-house resources or biocompatibility testing partners.  We also routinely define and execute various validation protocols supporting clinical/commercial approvals - everything from durability to manufacturing and sterilization.