When should you hire a quality manager for your medical device start-up?

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.

And we’ll be featuring practical insights from regulatory expert Sam Shelley.

The risks of waiting too long

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:

• Technical file rejections
• Failed inspections
• Incomplete Design History File
• Regulatory shutdowns

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.

Who’s doing the work—and when?

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.

Choose your eQMS consultant carefully

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

Why does this matter?

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.

So, when should your med tech start-up appoint a Quality Manager?

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

What does the quality road map look like?

📈 From consultant to embedded quality leadership: A roadmap for med tech startups

This “appoint-as-you-scale” model ensures compliance grows with your business, without introducing unnecessary overhead too early.

What will help you make these transitions easier?

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:

1. Treat your first consultant like a co-architect

• Choose someone who can maps quality processes to how you work
• Avoid off-the-shelf SOP libraries that don’t reflect your product or team.
• Insist on joint authorship of workflows to ensure alignment with future QA leaders.
  
  

2. Don’t let the tool dictate the process

Your eQMS should fit your business, not the other way round

Look for tools that offer:

• Customisable workflows that evolve as your processes mature
• Metadata-driven search to surface what auditors ask for - instantly
• Editable templates that reflect how you actually work
• Automations to streamline document review, approval, and training
• Regulatory compliance baked in—Part 11, ISO 13485, audit trails

3. Assign clear accountability before Stage 1 audit

Even if you haven’t hired a full-time Quality Manager:

• Appoint someone internally or externally to own the QMS
• Ensure they have decision-making authority and the right tools to see them through.

What next?

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.