Digital QMS and IVDR: What QA Leaders Must Get Right

IVDR Article 10(8) expects manufacturers to stay on top of their quality system, risk, and post-market data with evidence that’s current, not historical. That breaks most legacy systems.

Here’s why:

• Too Much, Too Fast: CAPAs, PMS, vigilance data, and change records move quickly. Manually updating all of it? Almost impossible.
• Too Many Silos: Risk files in one folder, SOPs in another, and design controls on someone’s desktop. It’s a mess. Auditors will find the gaps.
• No Real-Time Traceability: Notified Bodies don’t wait anymore. If your system can’t pull up clean, current records on demand, that’s a problem.

Bottom line? Paper systems aren’t just slow. They’re risky. They might’ve worked under IVDD, but they can’t keep up with the pace and scrutiny of IVDR.

We’ve spoken with QA leaders and IVDR programme directors across Europe. Their message is blunt:

• One diagnostics firm failed a surveillance audit after a hybrid QMS obscured their change control records.
• A German IVD scale-up delayed a product launch by 8 months because their legacy QMS couldn’t link design files to updated risk data.
• A Benelux-based manufacturer bought an eQMS but failed to validate it properly creating more risk, not less.

Going digital solves this. But only if you have the right people leading the shift.

1. You’re Ready for Audits Any Day of the Week

No more panic when the Notified Body sends an audit date. With a digital QMS, everything’s in one place controlled, timestamped, and trackable. Auditors want evidence, not explanations. A good eQMS lets your team show not scramble.

2. Risk Is Built into Your Workflows Not Bolted On Later

Under IVDR, risk management has to be live not a document you update once a year. In a digital system, risk is tied directly to your change controls, complaints, PMS, and CAPAs. That means you’re not managing risk in a spreadsheet while the product moves forward without it.

You reduce:

• Missed risk impacts
• Unexplained design changes
• Orphaned hazards

3. Your Team Gets Time Back

Manual signatures, email loops, copy/paste between Word and PDF those days are gone. eQMS platforms handle document control, approvals, and training assignments without the administrative drag.

Most teams see:

• CAPA closure times drop by 30–50%
• Faster onboarding and training validation
• Fewer errors from version mix-ups

That’s not about going “digital” for the sake of it. It’s about letting quality teams focus on real quality ,not chasing paperwork.

Buying the software is the easy part. Making it work across your processes, people, and priorities is where most organisations get stuck.

We’ve seen teams install eQMS platforms, but fail to:

• Validate the system for intended use (as required by IVDR)
• Migrate legacy data in a traceable, auditable format
• Redesign clunky paper workflows for the digital environment
• Train users properly especially operators, engineers, and cross-functional teams

A rushed rollout means new errors. Poor validation means audit risk. And frustrated users mean the system doesn’t stick. IVDR doesn’t care that you bought a system. It cares that it’s embedded, traceable, and actively used to control quality.

What most teams are missing isn’t software it’s leadership. Specifically, someone who can bridge quality, regulatory, IT, and operations.

This isn’t a checkbox hire. The best-performing diagnostics firms we work with have one thing in common: someone in QA owns the digital transition.

They:

• Translate IVDR and ISO 13485 requirements into digital workflows
• Lead validation efforts (CSV/CSA) with the right level of rigor
• Connect quality records across complaints, PMS, and risk files
• Coach the team on how to work differently not just where to click

This hybrid profile part quality engineer, part systems thinker, part operator is what makes or breaks a QMS upgrade. And it’s rare.

The companies that get this wrong often:

• Assign implementation to someone without regulatory experience
• Over-engineer validation and delay rollout
• Push too fast without user buy-in

The result? A system nobody wants to use and audit exposure that didn’t exist before.

Panda International partners with IVD firms across Europe to make digital QMS transitions successful.

We help companies:

• Find interim QA leaders who’ve delivered validated eQMS transitions
• Place permanent Quality Systems Managers with IVDR and ISO 13485 depth
• Recruit validation specialists who know what good looks like

We also support hybrid teams if you’re in remediation mode, sometimes a short-term expert is what keeps your timeline on track. This isn’t about “filling roles.” It’s about bringing in people who stabilise audit prep, protect market access and embed systems that actually get used.

Digital transformation is not optional it’s overdue. And the right hire doesn’t just reduce risk. They buy you time, compliance confidence, and a QMS that moves with your business.

If you are reviewing your diagnostics hiring plan, or want to pressure-test where risk sits across regulatory, quality, or clinical functions, we are happy to share market insight or talk through what we are seeing across IVD organisations today.

Get in touch with our expert below:

Cristina Ruiz

IVD Recruitment Specialist | Panda International

📩 c.ruiz@panda-int.com | 🔗 Meet Cristina