Medical Device Design Services

Life-saving medical devices

WE DESIGN RELIABLE, SAFE, AND EFFECTIVE MEDICAL DEVICES

Medical device design and development is where Synectic excels. For more than forty years, medical device design has been the core focus of our business model. As industry leaders, we have proven time and time again that we are the experts in getting medical devices to market. With our highly knowledgeable team of engineers, who have decades worth of medical device consulting experience, we overcome even the most daunting design challenges. Whether you need a Class I, Class II, or Class III medical device, Synectic has the capability and expertise to design and develop a reliable, safe, and effective medical device.

Quickly and cost-effectively pass FDA inspection and get your medical device into the hands of those whose lives depend on it. Experience has taught us to put risk assessment at the forefront of medical device design. Our process de-risks your medical device at every development stage. Our FDA-focused proprietary quality documentation system follows ISO 13485 quality standards. Combined with our medical device development process tailored around FDA design control requirements, we de-risk your device at every stage. We not only get your device to market faster but eliminate costly manufacturing and development do-loops.

CONTROL THE DESIGN PROCESS WITH OUR MEDICAL DEVICE DESIGN SERVICES

Medical Device Design & Development Plan

Start your project off right with a design and development plan. We work with you to establish a plan identifying the project scope and outlining responsibility roles for implementation.

Medical Device Design Inputs

Specify your medical device's physical and performance characteristics with our Product Development Specification (PDS). Design inputs ensure device requirements address intended use and user needs. We rely on clinicial feedback and market research to establish a solid PDS at the beginning of the project.

Medical Device Design Outputs

Get acceptable deliverables essential to your medical device. Design outputs include drawings, specifications, and instructions. At each stage of development, our engineers give you design outputs that meet or exceed acceptance criteria and match the defined design inputs.

Medical Device Design Review

Discover design problems early with design reviews at every stage. Our medical device designers will review and evaluate the current design against the design inputs established at the beginning of the project.

Medical Device Design Verification

Verify via measurable means that you designed the finished medical device correctly. Our engineers run various objective tests confirming that all design outputs match the design inputs.

Medical Device Design Validation

Validate via objective evidence that you designed the correct medical device. Our engineers will test the finished device under real-world conditions checking that it meets user needs and intended use.

Medical Device Design Transfer

Scale-up medical device production successfully with a design transfer plan. We work with you to make a plan defining the methodology and approach used to scale production without sacrificing quality.

Medical Device Design Changes

Be prepared for design changes before they happen with a medical device design change plan. Our engineers will establish and implement a plan for identifying, documenting, validating, verifying, reviewing, and approving any design changes before implementation.