Quality Management System Services
Move from prototype to design controls without changing teams
Most quality services sit apart from engineering, so the team that built your prototype hands off to people who’ve never seen it.
At Kickr, quality engineers work alongside the biomedical and design engineers doing your medical device development.
We can own the design and development work in your QMS, in ours, or in the one we set up for you. You stay manufacturer of record throughout.
Your first call is with an engineer, not a salesperson.
We’ll sign your NDA first, and you keep 100% of your IP
ISO 13485-based internal QMS, available for design and development work
Templates aligned with ISO 13485:2016 and the FDA’s QMSR, covering Class I through Class III devices
Quality engineers on staff, working alongside biomedical, mechanical, electrical and firmware engineers
Three ways to work with us
The right setup depends on whether you already run a quality system. We’ll recommend one on the first call.
For established device companies
We train to your SOPs, templates, document control and design review process, and our work goes straight into your Design History File.
For teams without a design controls process yet
We run design and development under Kickr’s ISO 13485-based QMS, and you own the records that come out of it.
For founders and new ventures that need their own system
We use templates aligned with ISO 13485:2016 and the QMSR to stand up a QMS scaled to your device class, then hand it to your team to run.
A clear path from proof of concept to design transfer
Every device program should start with Phase 0, the proof-of-concept work before formal design controls. ISO 13485 doesn’t require Phase 0 to be documented, but good records there save rework later. Once design controls begin, every step goes into your Design History File.
Under ISO 13485, the Design History File sits inside the broader Medical Device File. In Europe, it’s part of the Technical File.
Clear lines of responsibility
The manufacturer of record is the company whose name is on the label and on the FDA registration. That’s you, even when partners do much of the work.
Kickr can own:
- Design and development planning
- Design inputs, including user and product requirements
- Risk management and hazard analysis for the design
- Design outputs, specifications and design freeze
- Verification and validation protocols and reports
- Design transfer documentation
Stays with you:
- Your role as manufacturer of record, labeling and registration
- Ownership of the Design History File and Device Master Record
- Management review and internal audits
- CAPA and non-conformance
- Complaint handling and post-market surveillance
- Supplier qualification and ongoing supplier oversight
Start with a working prototype
Design controls build on a proof of concept that works. Our medical team takes programs through the process with engineering, machining, molding and assembly under one roof in Atlanta.
Start a conversation
Tell us where your program stands and how your quality system is set up today. An engineer will recommend the right way to work together.
FAQ
Engineering builds the product, while QMS is a documented system that proves it was designed, tested, and manufactured to a consistent, compliant standard. We can do both and blending them under one roof means your engineering and quality teams aren’t out of sync.
Yes, our QMS templates are compliant with 21 CFR 820 and ISO 13485:2016. We customize them to your specific product and company rather than handing you a generic document.
Every medical device sold in the US needs some level of quality system, but the rigor scales with device classification. Our templates cover multiple classes, so we can right-size the QMS to match your device’s actual risk level.
We primarily offer this as part of our integrated medical device development, because blending quality and engineering under one team is where we can help create the most value. However, reach out to our team and we can talk through your specific situation.