Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible. The pace of innovation in the industry has increased tremendously, thanks to more options for outsourcing and new technology like 3D scanning and AI analysis. 

On top of that, venture capital is concentrating in fewer, more mature companies, meaning early-stage companies are often facing pressure to do more with less. That creates its own set of challenges. Even with the best software tools and new technology at their disposal, medtech companies have to figure out how to extend their runway and hit milestones with fewer resources.

One of the best ways to maximize runway is to keep head count from growing unnecessarily during the early days. But that’s often easier said than done. As design and development progresses, the complexity of most teams’ quality systems will steadily grow until they need to hire full-time QA professionals to handle it.

But is this the only option? Or is there a way to delay team expansions while staying compliant and building an audit-ready QMS?

The hidden costs of a paper system

To control costs, a lot of medical device companies make the same decision early on: They choose a DIY “paper” QMS. Instead of purchasing dedicated QMS software, they house their quality system in a variety of generic software applications. This is typically some combination of Google Drive, Sharepoint, Dropbox, Excel, or similar tools.

It feels smart at first. But the DIY approach is a trap.

The short-term benefits of a paper QMS solution are obvious: The tools are free or relatively cheap, and teams can get started with them immediately. Everyone is already familiar with Drive or spreadsheets, the thinking goes, so there won’t be any need to hire someone to manage the QMS. After all, quality should be everyone’s job.

Unfortunately, the cheapest choice usually ends up costing far more later on. That’s because without a full-time QA hire, the product team has to maintain the QMS. They quickly get bogged down in documentation, trying to do the job they were hired for and manually manage traceability and version control across disconnected documents and systems.

Not only does this begin to delay timelines, but as the team gets closer to submission, it becomes clear that the QMS might not be in an audit-ready state. This sets off alarm bells for everyone. The team must scramble to update the quality system, and executives find themselves answering hard questions from investors about whether the company is ready for submission and subsequent audits.

This goes on until frustration with the QMS reaches a boiling point and leadership makes its first QA hire (or a pricey consultant), whose first job is simply to clean up traceability gaps in the QMS.

In the end, the paper system creates every issue the company was hoping to avoid: compliance risks, early expansion of head count, and increased costs that shorten their runway.

What other options do they have? Older legacy systems require extensive customization and implementations that drag out for months on end. Some newer options bill themselves as fast and user-friendly, but they lack medtech-specific features, and their limited alignment to medical device regulations and standards (like ISO 13485 and ISO 14971) can leave companies exposed during audits.

How to extend the runway without overexpanding your team

The best way to keep head count under control early on is to choose tools that reduce the need for new hires, rather than increase it. For early-stage medical device companies, that means choosing a QMS solution that allows the product team to own quality early on without getting bogged down in busywork.

It sounds nice in theory, but what does that look like in practice? At a minimum, that QMS solution would have to be:

Built for product development, not just quality. In other words, this solution should ease the burden of documentation for product teams, integrate with their favorite tools, and allow them to work at the speed they’re used to.

Modern and easy to use. A clunky and outdated UX is the bane of product teams, especially software developers. If product teams are going to be responsible for compliance, they need a solution that’s easy to work with, intuitive to navigate, and doesn’t require extensive customization.

Aligned with medtech standards and regulations. This last point is essential. For teams to delay a QA hire, they need a QMS solution that does not sacrifice compliance for speed or ease of use. The QMS solution would need to be aligned to medtech regulations like 21 CFR Part 820 and standards like ISO 13485 and IEC 62304.

When teams do eventually make their first QA hire, the best QMS solution will redefine the quality manager’s role—away from policing to more strategic and effective work.

Fortunately, there is a QMS solution that meets all these criteria: Ultralight by Greenlight Guru. Ultralight was built to delay your first QA hire, not force it. By focusing on the needs of product-led teams, Greenlight Guru has built a QMS that’s lightweight and flexible but without any trade-offs when it comes to regulatory compliance.

How to know when you’re ready for your first QA hire

To be clear, no matter how well your QMS solution works for your product team, there will come a time when you need dedicated QA hires. Think of it like any other function within a growing company: The company’s founders might be heavily involved with selling or marketing the product, or even providing customer support. But at a certain point, the volume and complexity of those responsibilities requires a dedicated employee.

Similarly, you’ll reach a point where you need someone (or even a team) monitoring quality full-time. Just like a marketing manager monitors company communications, or a sales director monitors the sales process, a QA professional is there to ensure adherence to standards and consistency across departments.

So, what are some signs that you’ve reached the point where not having a QA professional on the team is no longer cutting it? Signs may include:
• Inconsistent quality processes across different functions within the business
• No clear owner for audit preparation
• Engineers spending more time on traditional quality work than development

Ultralight is built to help delay the onset of these issues. When the time comes, don’t wait to make your first QA hire. But with Ultralight, you may have more room to grow than you think.

Get a QMS that’s built for speed and medtech compliance

Early-stage medtech teams need a QMS that lets product teams focus on development while compliance builds in the background.

Ultralight by Greenlight Guru is the fastest way to stay compliant without slowing down your team. Ultralight provides a modern and lightweight QMS solution that’s backed by a dedicated team of medtech experts who are there for you every step of the way. 

Published Dec. 3, 2025, by Greenlight Guru.