A quality system your team can run
I build quality management systems that meet the requirements of ISO 13485, EU MDR, FDA QMSR, and MDSAP. I start from a system I've built that already meets the requirements, or update the system you already have, and adapt it to your company and the way you work.
Three situations where this works best
You have a device in development and need a quality system in place before the certification audit.
It was written for ISO 13485 alone, or for the MDD, and now has to meet EU MDR, FDA QMSR or MDSAP as well.
The system exists on paper, but what the team does every day looks different.
You are preparing for your first certification
Your system was built for another framework
The procedures and the practice have drifted apart
You need ISO 13485 certification, and you don't have a quality system yet.
You're entering the US market, and your system needs to comply with FDA QMSR.
You plan to sell in several MDSAP countries and want one audit to cover them.
Your procedures were adapted from a template, and the team doesn't follow them.
An audit is coming, and you are not sure the system will hold up.
You've started development and you want to get it right the first time
You probably need this if one of these sounds familiar
A system built for your company
Processes sized to your team and your device, not a generic template.
I sit with the process owners, so the procedures describe how the work is really done.
Internal audits and preparation for your team before the certification body arrives.
Your team knows how to use it, and it keeps working after certification.
A system that fits
Processes written with the people who run them
Ready for the certification audit
A system you can keep running
From a first conversation to the work itself
You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first.
When needed, I go through your procedures, your technical file or your most recent audit reports.
The scope of work, estimated hours and a timeline. I work by the hour.
I work with your team on what the company needs at that stage, and we meet regularly for updates.
A first conversation
Looking at what you have
A clear proposal
The work itself
One company I work with develops only software, and its product is based on artificial intelligence. They came to me without a quality system, and I'm building one with them from the ground up, sized to fit a software company and the way it develops its product.
Another company already has a quality system in place, and my job there is to keep it current as the regulations change.
Two companies, two starting points
Yes. I come with a quality system I built that already meets the regulatory requirements, and I adapt it to your company and the way you work. You don't start from a blank page.
Yes. I build or upgrade the quality system, run internal audits and prepare your team for the certification audit. The certificate itself is issued by an accredited certification body.
No. If I built your quality system, or ran it as your quality manager, I don't run its internal audit, so the audit stays objective and independent. I bring in an external auditor you approve in advance.
Do you work with early-stage companies that don't have a QMS yet?
Can you help us get ISO 13485 certified?
Can you audit a quality system you built for us?
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A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.