How Much Quality System Do You Actually Need?
Right-Sizing the Move from Paper to eQMS
Insights from a Medical Device founder, a quality consultant, and Grand Avenue Software
The Audit Self-Test
An auditor sits down across from you and asks for four specific document references — plus the change orders that put each one in place. How long until you’re back with them?
Nathan Friedman, CEO of HemaSense, uses that scenario as a gut check for early-stage teams. “If that scares you to death, because you’re sitting there saying, ‘I don’t know how I’d find that,’ maybe you should put a little more structure in place,” he says.
That question sits at the center of this report. It draws on a panel conversation among Nathan, quality consultant Jenn Zuba of Cooperative Quality Solutions, and Grand Avenue Software Vice President Steve Cohen about when, why, and how Medical Device companies should move from paper to an electronic quality management system (eQMS).
What stood out was what the panel didn’t say. No one argued that every company needs an eQMS tomorrow. They argued for making the decision on purpose, based on your team, your stage, and where the business is headed, before a deadline makes it for you.
Paper Works — Until It Doesn’t
Jenn’s test for when to switch is simple: the moment you can’t find what you need to do your job.
That might be the complaint data for a trend analysis, the nonconformance records behind an annual supplier evaluation, or just the current revision of a document you need to revise again. Once the time spent digging through folders, binders, and desktop files outweighs the cost of implementing an eQMS, the math has changed.
Until then, paper can be the right answer. Jenn works with clients who run paper systems well — teams where everyone has 15 or more years in the Medical Device industry and follows procedures closely. “If paper is working for you, great. Keep on it,” she says.
The trouble starts when the team doesn’t have that background. Founders coming from academia or from non-regulated industries often haven’t worked inside a quality system before. On paper, that shows up as missed signatures, documents that never get printed, and records filed in the wrong place — or not filed at all — until someone asks for them.
Nathan frames the decision the way most founders will: where do we spend our time and money, and which risks could stop us from reaching the next milestone? If your team’s experience keeps that risk low, there’s no reason to take on more system than you need. If it doesn’t, structure is a good place to invest.
Where Paper Breaks: The Source-of-Truth Problem
Paper and folder-based systems tend to fail in the same few ways. Jenn sees them constantly.
The wrong revision gets revised. Rev 2 is in the official binder on the shelf. Rev 1 is in a folder on someone’s desktop. That’s the one they open, edit, and route for approval.
Released documents never reach the binder. The change is approved, but the printed copy never gets filed. When an auditor asks for the current version, it isn’t there.
Critical records live on one person’s laptop. This is the costly one. Jenn once started working with a company in the middle of a nonsignificant risk (NSR) study. She asked for the study protocol, the device drawings, and the software version under evaluation. There was nothing. “That was just stored on my computer,” they told her. “And at that point, my heart dropped,” Jenn says.
Without documentation of exactly which device and software configuration was tested, the company had no way to connect its study data to the product it would eventually submit. The first priority became getting document control running immediately, so every drawing and software version could be captured before more work built on top of it.
The flip side shows up in day-to-day work. When an investor asks Nathan how HemaSense ran a past study, he calls his CTO. The answer is usually the same: “It’s in Grand Avenue. Go look it up.”
For Nathan, that’s where the value becomes obvious. The record isn’t one of several drafts in a shared folder — it’s the source of truth. That matters for regulators, and it matters just as much for development teams who need to know exactly what they did so they can repeat it and trust the results.
The Conversion Tax
Many teams plan to move to an eQMS when they scale up or start preparing for an audit or submission. Jenn thinks that’s waiting too long.
Those are the busiest stretches a young company goes through. You’re negotiating distribution agreements, scaling manufacturing, qualifying new suppliers, and making sure your documentation is in order. Adding a software implementation to that list makes a hard season harder.
There’s also a cost that rarely shows up in early planning. If you build a paper QMS first and migrate later, implementing the software is only part of the job. “You have to revise all of your policies and procedures to reflect the use of the new software,” Jenn says. Your document control procedure, your nonconformance procedure, and every other process written for paper all need to be rewritten for the new system.
That conversion work is what companies underestimate most, and it grows with every procedure you add on paper. It’s why Jenn’s advice comes with a clear condition: “It is better to start with an eQMS than it is to start with paper, if you think you might eventually get there anyway.”
Plan for the paper, too. When you do migrate, decide early what happens to existing records. Some companies keep their paper records and set a cutover date, after which everything new goes into the eQMS. That lightens the implementation. Others digitize everything so they can retire the hard copies and maintain a single system — more work up front, less long-term upkeep. Either approach works, as long as you meet your document retention requirements and build the decision into your implementation plan.
Right-Size to Your Team, Not Your Milestone
It’s tempting to tie the eQMS decision to a regulatory milestone, such as ISO 13485 certification or a 510(k) submission. Both panelists pushed back on that. The real trigger is whether your team can reliably run a less structured system and produce records when asked.
For HemaSense, the moment came about a year after the company was founded. The team had just finished its first animal study to prove technical feasibility, and they asked themselves a forward-looking question: would they want this work documented as a snapshot in time, locked down so they could reference it to support future submissions and development?
The answer was yes, which meant they needed revision control. From there, they worked out what the surrounding quality system should look like, so the next piece of work would have somewhere to go. They also wanted to avoid the scenario Nathan described as being “under the gun” — a huge stack of documents that should have been in a quality system, with no way to go back in time.
Start with what you need now. HemaSense began with document control and the foundational procedures. Complaint handling and nonconformance modules came later — or haven’t yet — “because we don’t need them yet,” Nathan says.
Jenn gives startups the same advice. A company still in design and development won’t be receiving complaints for years, so there’s no reason to pay for complaint handling today. Early on, most teams need Document Control, Training Management, and possibly Risk Management. (Training Management requires Document Control.) Grand Avenue Software’s modular structure lets companies start with those and add modules as development progresses.
One thing to plan for: adding a module later brings a re-validation step. That’s normal across the industry, and it’s easier to budget for when you expect it.
Choose Deliberately, Not Under Pressure
Platform selection deserves more time than most teams give it. Nathan found the evaluation itself valuable. Seeing how different platforms handle the same work showed him what each one is designed around, and what HemaSense would be deliberately giving up or putting off with each choice.
His firmest advice: don’t start the process with an audit a month away. Take the time to understand what’s available, where your company is today, and where you expect it to be.
Don’t overbuy. Integrated platforms that combine quality, accounting, ERP, and traceability exist for Medical Device companies. They’re powerful, and for the right company they may be worth the higher cost and larger implementation. But Jenn cautions that these systems are highly configurable, and that’s a burden if you don’t already know exactly what you want. Most startups don’t, yet.
Steve has seen the same pattern with manufacturing plans across Grand Avenue Software customers of all sizes. If you know you’ll manufacture in-house, you’ll need an ERP or MRP system at some point, and having it integrated could be a real advantage. If you might use a contract development and manufacturing organization (CDMO) instead, you could spend years paying for an ERP system you never needed.
Don’t underbuild, either. Nathan points out the opposite risk. Make short-term choices without thinking about how your systems connect, and you may wake up one day needing to operate in 15 different systems to complete one transaction.
What to evaluate. The factors the panel returned to most:
- Team experience. How much time has your team spent working inside a Medical Device quality system?
- Team location. Distributed teams are common. Jenn has one client with team members in West Virginia, outside Mexico City, and in Texas. An eQMS built for 21 CFR Part 11 compliance lets people review and approve records wherever they work.
- Time and cost to implement. For startups, these usually matter most. Ask what shortens the path, such as pre-built templates.
- Validation deliverables. Ask exactly what the vendor provides. Grand Avenue Software includes acceptance testing, a validation letter, and checklists as standard.
- Migration support. If you already have a paper or folder-based system, find out how the vendor will help convert forms and templates and align your procedures with the new system.
- Room to grow. Can you add capabilities as you need them, and how will the system connect with other business tools later?
One Startup’s Path
HemaSense brought in a quality consultant before looking at any platforms, to understand what had and hadn’t worked in systems she’d used before.
- Evaluation: About six weeks of demos, test logins, and walkthrough videos across several platforms
- Configuration: Three to four weeks of training and testing in a test environment, working out how to configure Grand Avenue Software for the system the team had in mind
- First documents: Roughly another month to get the first controlled documents in place
Jenn notes why it moved quickly: HemaSense had no existing QMS to convert, and the team knew what it needed going in.
This is one company’s experience, not a benchmark. Implementation time depends on the number of modules, company size, and the volume of records being migrated.
Readiness Check
Answer each question yes or no.
- Can you find the current revision of any controlled document in a few minutes?
- If an auditor asked for a specific document and the change orders behind it, could you produce them without a search?
- Could you show exactly which device and software configuration was used in your most recent study or test?
- Has everyone on your core team worked inside a Medical Device quality system before?
- Do you have a clear, calm window in the next several months — before scale-up, a submission, or an audit — to implement a new system?
- If you expect to move to an eQMS eventually, have you accounted for the work of rewriting your procedures later?
Mostly yes? Your current approach may be working. Revisit it when your team grows or your plans change.
A no on questions 1–4? Those are the gaps that paper systems handle worst. It’s worth adding structure, starting with document control.
A no on question 5 or 6? The best time to act may be sooner than you planned, while you still have room to evaluate and implement without a deadline.
The Bottom Line
Moving to an eQMS is a lot of work. Jenn is candid about that, and she’s equally clear that the right planning and the right tool keep the work manageable. Nathan’s closing advice is to resist one-size-fits-all answers: make the decision in the context of your own company, your team, and your stage.
If your team hasn’t run a quality system before, or has only worked in one, outside expertise helps. Someone who has seen multiple platforms can speed up the comparison and help you match a system to where you are.
Contributors
Jenn Zuba, President, Cooperative Quality Solutions
Cooperative Quality Solutions is a Medical Device consulting firm that helps startups build quality systems that fit their stage. It brings more than 20 years of product development experience across Class I–III devices.
Nathan Friedman, CEO, HemaSense
HemaSense is developing a patient-monitoring device that detects subcutaneous bleeding in recovery after catheter-based procedures. Nathan has more than two decades of Medical Device design, development, and commercialization experience, including years at W.L. Gore & Associates.
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