Services

Design and development across the whole device

Mycel does the core mechanical and systems work directly, and connects specialists for the disciplines around it. Either way you have one contact and one agreement.

Core

Done by Mycel

Mechanical design

Concept through design transfer for electromechanical devices, disposables and fixtures.

Typical deliverables

  • CAD models, assemblies and drawings
  • Mechanisms and enclosures
  • Tolerance analysis
  • DFM/DFA review with your suppliers
  • BOMs and release packages

Systems & design controls

Requirements that trace, risk inputs that hold up in review, and design history file documentation, written to your quality system’s procedures. Built on nearly 12 years of work inside ISO 13485-certified quality systems.

Typical deliverables

  • Requirements and traceability
  • Design reviews
  • Risk management inputs (ISO 14971)
  • Design history file documentation

Prototyping & test

In-house prototypes, fixtures and bench tests that answer questions early, before tooling money is spent.

Typical deliverables

  • Rapid prototypes in engineering and composite materials
  • Test fixtures
  • Bench testing and design of experiments
  • Verification protocols and reports

Analysis & simulation

FEA and CFD run alongside the design work. Used to compare options, find failure modes early and plan verification. With credibility established under ASME V&V 40, a model can stand in for a test that can’t be run directly.

Typical deliverables

  • Structural and thermal FEA
  • CFD for flow, pressure drop and shear
  • Mechanism and dynamics analysis
  • Model credibility plans and reports (ASME V&V 40)
  • Analysis reports for the design history file

Technical & program leadership

Senior technical leadership for a program or a workstream, plus improvement of the development process itself.

Typical deliverables

  • Scoping and estimates
  • Schedules and risk registers
  • Design review leadership
  • Development process improvement

Connected

Through independent specialists

These disciplines are delivered by independent specialists who run their own practices. Mycel scopes the work, contracts them and coordinates delivery, so it reaches you as one program.

Human factors & usability

Use-related risk analysis, formative and summative studies, and usability engineering files to IEC 62366.

Industrial design & UX

Form, ergonomics, colour-material-finish and user interface design.

Electrical & electronics

Circuit and PCB design, power, sensing and electrical test.

Firmware & embedded software

Embedded control, with a software lifecycle to IEC 62304.

Quality & regulatory

QMS support, submission strategy, and 510(k) and De Novo preparation.

Beyond medical devices

Most of our work is in medtech, where design controls and risk management are part of every step. The same discipline carries over to other complex hardware, including sport and consumer products.

Not sure which of these you need?

Describe the problem and where the program is. We’ll suggest a scope, or tell you if someone else is a better fit.

Start a conversation

Or email hello at myceldesign dot com