Change control and ECOs after certification
After certification, design, supplier and process changes each need a regulatory assessment. I set up change control that checks the impact of every change, and help you decide when the notified body or the FDA needs to know.
Three situations where this works best
Design changes move faster than anyone can assess their regulatory impact.
A change in production can affect validation, risk and the technical file.
Some changes need the notified body's approval or a new FDA submission, and some don't.
ECOs are piling up
You changed a supplier or a process
You are not sure what to notify
Changes are approved without a regulatory impact assessment.
Your technical file no longer matches the product you ship.
You don't know whether a change has to be reported to the notified body.
An auditor found changes that weren't documented.
Your engineering and quality teams use different change processes.
You probably need this if one of these sounds familiar
Every change assessed, and the file kept current
One route for every change, sized to its risk.
For each change: what it affects and who needs to know.
The documentation follows the product as it changes.
Changes documented the way auditors expect to find them.
A change control process
Regulatory impact assessments
A technical file that stays current
Fewer surprises in audits
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
At a dental navigation company I support on an ongoing basis, I take part in the ECO process. For each change I check what it touches on the regulatory side, from the technical documentation to the risk file, before it is approved.
Every change, with its regulatory impact
Both are possible. Many clients start with a project and continue with a few hours a month of ongoing support. I work by the hour, and offer a fixed price only when the scope is closed and known in advance.
Both. I can be your QA/RA manager, or work alongside the QA/RA manager and team you already have.
It depends on the scope. I work by the hour, and after a first conversation, and sometimes a look at what you already have, I send a proposal with the scope, estimated hours and timeline.
How do engagements typically work – project-based or ongoing?
Can you support an existing team, or only work as the sole QA/RA resource?
How much does it cost?
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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.