We build quality in from day one.
We're ISO 13485:2016 certified by LRQA for the contract development and manufacturing of medical devices and IVDs.
Your product needs a QMS too.
If you're building a medical device or IVD for a regulated market, you need a Quality Management System. Building one from scratch takes time most teams don't have.
Our own ISO 13485 certification covers contract development and manufacturing of medical devices and IVDs, and we help you build yours, shaped around your product and the market you're entering, so it's ready when you need it.
Talk to us Our own ISO 13485 certification covers contract development and manufacturing of medical devices and IVDs, and we help you build yours, shaped around your product and the market you're entering, so it's ready when you need it.
Your product needs a QMS too.
The challenge
If you're building a medical device or IVD for a regulated market, you need a Quality Management System. Building one from scratch takes time most teams don't have.
Our own ISO 13485 certification covers contract development and manufacturing of medical devices and IVDs, and we help you build yours, shaped around your product and the market you're entering, so it's ready when you need it.
Talk to us Our own ISO 13485 certification covers contract development and manufacturing of medical devices and IVDs, and we help you build yours, shaped around your product and the market you're entering, so it's ready when you need it.
How we support your QMS.
01
QMS Development
We build the Quality Management System your product needs, from the ground up, covering the documentation and procedures it actually requires.
02
QMS Alignment
When we work together, we make sure your QMS and ours fit together, so projects move smoothly between your team and ours.
03
Regulatory Compliance
We help you meet the regulatory requirements that apply to your product and your market.
We save time by letting automation write the paperwork.
We use automation, enhanced by AI, to generate much of our QMS documentation directly, cutting the time we used to spend on admin. The same tools help catch inconsistencies in records early, before they become a problem.
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Quality from the start
We don't add compliance at the end of a project. Quality is part of the plan from the first experiment through to final release.
Quality from the start
We don't add compliance at the end of a project. Quality is part of the plan from the first experiment through to final release.
Full traceability
Every material, process, and result is documented and traceable, ready whenever a regulator or client needs to see it.
Full traceability
Every material, process, and result is documented and traceable, ready whenever a regulator or client needs to see it.
We use what we build
We're ISO 13485:2016 certified ourselves, so we know exactly what a working QMS needs to look like. We live inside one every day.
We use what we build
We're ISO 13485:2016 certified ourselves, so we know exactly what a working QMS needs to look like. We live inside one every day.