Services

Medical Device Engineering

Designing a medical device is tough. It requires inspiration, commitment, and most likely help from an expert. We offer turnkey or partial product development with an emphasis on innovative industrial/mechanical design and electrical engineering. We can manage your entire project or develop and document the pieces that you don’t have the bandwidth or skill-set to accomplish.
  • Proof of concept development
  • Industrial design
  • Mechanical engineering
  • 3D printing
  • Schematic capture
  • PCB layout

Regulatory

Quality, risk, safety, EMC. These are a few of our favorite things. When the regulator knocks, when requirements aren't developed, when traceability fails... I simply remember there's TCMC, and then I don't feel so bad.
  • ISO 13485 compliant QMS
  • Safety compliance per IEC 60601-1
  • EMC compliance per IEC 60601-1-2
  • Risk management per ISO 14971
  • Requirements definition & traceability
  • Design verification and validation
  • Process development

Project Planning

TCMC follows the medical device development (MDD) life cycle model. We've developed a unique system that allows us to quickly assess your product and create a project plan with configurable templates that drastically reduces your documentation workload, so you can focus on actual device development.
  • MDD lifecycle model based projects
  • Milestone based development
  • Financial planning

Clinical Studies

We will design a clinical study that demonstrates the safety and effectiveness of your medical device. From protocol development, managing multi-center study sites to statistical analysis of data, our team's rigorous approach to clinical trials will meet your clinical requirements.
  • Clinical investigation plan per ISO 14155
  • Clinical pathway design 
  • Clinical trial oversight
  • Principal Investigator for clinical trials

Human Factors

Human factors ensure that your medical device is safe for the patient and clinician while maintaining the best user experience possible. TCMC works with your team to develop a medical device that operates safely and in a controlled, expected manner in every situation.
  • Usability engineering per IEC 62366
  • User experience
  • Human factors
  • Usability studies (formative and summative)
  • Market research

Software & Embedded Design

Our experience with software development for medical devices ensures that we quickly and cost effectively complete your project. Our projects range from drafting software development plans that fit in your team's development hierarchy to assembly level μC coding to designing neural networks that crunch your clinical data.
  •  IEC 62304 based software development plan
  • Wireframing
  • Software architecture
  • Embedded development
  • Software development
  • Software verification and validation
Lewis Crenshaw
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Nothing to it but to do it.
Abraham Lincoln
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Give me six hours to chop down a tree and I will spend the first four sharpening the axe.
Matthew Thoresen
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We’ll figure it out, we always do
Matthew Thoresen
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Start a project only after it’s finished
Matthew Thoresen
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Over promise AND over deliver
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