WOULD YOUR MEDICAL DEVICE COMPANY PASS AN ISO13485 INSPECTION TODAY?
Seeking initial ISO 13485 certification, or facing a surveillance audit you're not fully confident about?
ISO 13485 certification isn't a one-time hurdle — it's a standard your company has to keep meeting, audit after audit, as your device portfolio and your regulatory footprint (TGA, MDSAP, EU MDR) grow. Medical device companies rarely lose certification over one dramatic failure. It's usually a design control gap that was fine at a smaller scale, a risk management file that hasn't kept pace with ISO 14971 expectations, or a CAPA program that closes actions without genuinely closing the loop.
For companies working toward initial certification, the risk looks different but the root cause is the same: documentation, processes and design history built quickly to get a product to market, without being well tested.
The ISO 13485 Medical Device Inspection Readiness Scorecard is a free, 20-question self-assessment that checks your documentation, design controls, risk management and team audit confidence against ISO 13485:2016 and current regulatory expectations — before your auditor does.
What You'll Learn
How strong your QMS, documentation and design-control systems really are, measured against ISO 13485:2016
Whether your risk-management and CAPA programs meet ISO 14971 and ISO 13485 requirements — not just on paper, but in practice
How confident your team would be under live audit questioning, and where the gaps in that confidence sit
How your systems align with TGA, MDSAP and EU MDR expectations, not just the base ISO standard
Your next steps to achieve or maintain certification with less last-minute pressure
Who This Scorecard Is For?
Medical device companies preparing for initial ISO 13485 certification
Companies facing a surveillance or recertification audit and wanting an honest read before the auditor arrives
Device companies expanding into new markets (EU MDR, MDSAP) that bring additional Notified Body scrutiny
Quality and regulatory leads at scaling medtech companies without a large in-house compliance team
Why This Scorecard, Why QSN?
QSN works with medical device companies through the full ISO 13485 pathway — gap assessment, QMS, design and development, systems and process development, facility and equipment, and direct audit preparation. This scorecard reflects the same areas we work with clients preparing for ISO accreditation or recertification.
What Happens After You Complete It?
You'll get a readiness picture across QMS, design and development, risk management and your processes and systems, plus team audit confidence. We'll send you a followup email to see how you went. If you need support to navigate an accreditation or just a recommended next step, then reach our and book a call with us.
