CAD for medical device design
In short
CAD for medical device design means designing instruments, implants and equipment in a CAD and PDM setup whose outputs, changes and tools hold up in a quality management system to ISO 13485. We deliver CAD, PDM and automation work that fits your QMS; regulatory decisions stay with your quality and regulatory team.
Updated 27 Oct 2026
Medical device manufacturers design under document control. Every model, drawing and change has to be traceable, and tools that produce design outputs may need validation. We build CAD automation, PDM workflows and size ranges in Solid Edge, SolidWorks and Inventor with that in mind, together with your design and quality teams.
- Typical systems
- Solid Edge, SolidWorks, Inventor, SolidWorks PDM, Autodesk Vault
- Start with
- Intro callfree, 45 minutes
What slows design down
Validation for every tool
Macros, configurators and AI tools that touch design outputs need a validation that fits the QMS.
Changes with evidence
Every design change needs its reason, review, approval and risk impact on record.
Many sizes, one design
Instruments and implants come in size ranges, each size with its own drawing and part number.
Solutions for this industry
Validated CAD automation
A Solid Edge or SolidWorks macro that fills title blocks, a configurator that sizes a part and an AI tool that checks drawings all produce design outputs. In a medical device company, such tools can count as software used in the quality management system, and an auditor may ask how they were validated.
Learn more →Traceable design changes
A dimension on an implant changes after a complaint. The auditor asks which requirement it serves, which risk control it touches, who approved it and which drawings and parts changed with it. When the answers sit in emails and file names, finding them means searching folders and inboxes.
Learn more →Size ranges for instruments and implants
A bone plate comes in several lengths, a reamer in a series of diameters, a trial implant in every size of the implant. Each size needs its own model, drawing, part number and BOM. When sizes are copied by hand, a dimension changed in one size is easily missed in the next.
Learn more →
Frequently asked questions
What does ISO 13485 require for the design and development of medical devices?
ISO 13485:2016 clause 7.3 requires planned and documented design and development, covering inputs, outputs, reviews, verification, validation, transfer and the control of changes. It does not prescribe CAD or PDM tools, but the records they produce must be controlled and traceable. Which requirements apply to a specific product is decided by the manufacturer's quality and regulatory team.
What is a design and development file under ISO 13485?
The design and development file, required by ISO 13485:2016 clause 7.3.10, is kept for each medical device type or family. It contains or references the records that show conformity with the design and development requirements, including records of design changes. Many of these records are CAD models, drawings, BOMs and change orders stored in the PDM, so a clean PDM structure makes the file easier to maintain.
How did the FDA QMSR change design controls in 2026?
Since 2 February 2026, the FDA's Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference into 21 CFR Part 820 and replaces the former Quality System Regulation. Design and development requirements therefore follow ISO 13485 clause 7.3, supplemented by FDA-specific provisions in Part 820. How this affects a specific company is a question for its regulatory affairs team.
Can AI be used in medical device design?
Yes, for preparing and checking tasks such as filling drawings, checking models against design rules or building size ranges, as long as an engineer confirms every output. AI tools that touch design outputs count as software in the quality management system and need validation proportionate to their risk. AI inside the device itself is a separate topic, governed by medical device software rules.
Talk to us about your task.
In the free 45-minute intro call we show a live demo on comparable geometry. Someone from our team replies personally within one working day.