Bringing a medical device to market is one of the most rewarding and high-stakes journeys a startup can undertake. But while most founders obsess over functionality and funding rounds, many underestimate the critical timing of a much less glamorous task: appointing a Quality Manager.
Delaying finding dedicated support for quality management can put your entire product strategy - and even your company — at risk. In this guide, we explore why, when, and how to appoint a Quality Manager to scale your compliance processes with confidence.And we’ll be featuring practical insights from regulatory expert Sam Shelley.
According to Sam Shelley, one of the most common mistakes medical device start-ups make is to bodge their SOP documentation:
"Probably the one mistake that has the most lasting effect', Sam says, 'is not actually understanding the user requirements... But close second to that is paying lip service to putting in procedures that don't necessarily reflect what you do."
Failing to document procedures properly can store up problems for you later on, including:
These aren’t just hypothetical risks - they’re real pitfalls that have derailed even the most promising innovations.
They arise, not always from businesses trying to cut corners, but from the absence of someone who understands how to embed quality and compliance into a company's operations from the start.
Startups often ask:
“Do we need to hire a full-time Quality Manager now?”
But the more useful question is:
“Has someone taken ownership of quality and compliance?”
At the beginning, that might mean a consultant who can help you build a foundation for your quality strategy.
WATCH: Quality consultant Sam Shelley explain why early expert help is essential:
Part of this process maybe to find the support to build the foundations of the eQMS (electronic quality management system) that can evolve with your project.
Hiring a consultant or contractor is often the right call at first, especially if you're operating on limited resources. But Shelley cautions:
“If you're going to go out and get somebody to help you build a quality management system, make sure that their approach is to build the system with you rather than just give you a system you must adapt to.”
WATCH: Sam Shelley explain the danger of ‘buying in’ quality
An off-the-shelf QMS that prescribes SOPs, is like a strict diet you didn’t choose. You won’t stick to it. You need systems and processes that match how your business works, not generic ones handed to you in a PDF.
That’s where a good quality consultant or contractor earns their stripes - they will help you tailor compliance processes to fit your team, your workflows, and your product.
What’s more - they will help you do this in scalable ways, suggesting the structures and digital tools that will allow you to adapt your process even as your product matures.
This it not something that every digital eQMS allows. As one ex-Greenlight Guru employee admitted:
“You'll find that customers churn off Greenlight Guru because even small companies are going to hire someone who is an expert in managing corrective, preventative action and they have a particular way they want to do it. However, Greenlight enforces a rigid, unchangeable approach, which creates friction."
You need to ensure that the system you are creating with a consultant can be adapted to reflect the priorities and preferences of any future quality leader you appoint.
By the time you're preparing for your Stage 1 audit, a Quality Manager should already be in place.
WATCH: Sam Shelley explain when you’ll need a designated Quality Manager within your business
Stage |
Who Leads Quality |
Key Focus Areas |
eQMS requirements |
1. Seed / R&D Phase |
Internal champion or external consultant |
|
|
2. Pre-Certification |
Contract/Part-time Quality Manager |
|
|
3. Certification & Audit Prep |
Full-time Quality Manager (or equivalent role) |
|
|
4. Post-Certification / Scaling |
Embedded QA team or Head of Quality |
|
|
This “appoint-as-you-scale” model ensures compliance grows with your business, without introducing unnecessary overhead too early.
Delaying quality hires or picking the wrong tools early on can derail your trajectory. But scaling compliance doesn’t have to be painful. Here’s how to ensure seamless transitions from scrappy startup to structured governance:
Your eQMS should fit your business, not the other way round
Look for tools that offer:
Even if you haven’t hired a full-time Quality Manager:
Thinking about your quality management role too late can be an expensive and embarrassing mistake. Build your compliance foundations early and evolve them as you scale. Whether it’s a consultant or a full-time hire, make sure quality managers or contractors are building a system with you, not for you.
Need help laying the groundwork? Talk to us at Cognidox. We've helped hundreds of medical device companies like yours grow from ambitious startups to audit-ready global tech leaders, with compliance that scales.