Seven categories
Security, QMS, PLM, validation and usability, onboarding and support, vendor reliability, and commercial terms. Each criterion names the question to ask and the evidence to request.
Resource · Excel template
Choose your next QMS or PLM with evidence you can explain.
A free Excel workbook for medtech teams. Compare up to 10 QMS and PLM providers on the same criteria, the same evidence standard and the full cost of ownership.
Why evaluate your QMS
Your quality evidence lives in this system.
The system you choose runs your quality system.
Document control, CAPA, training records, supplier approvals, design history and audit trails all live inside your QMS and PLM. When the fit is weak, the gaps surface during an audit, a submission or a field issue. That is the most expensive moment to find them.
ISO 13485 asks you to validate the software used in your quality management system for its intended use, before first use and after changes (clause 4.1.6). It also treats the provider as a supplier you evaluate and select against documented criteria (clause 7.4.1). The evaluation is where both of those records begin.
A structured evaluation gives you three things: a shortlist built on demonstrated capability, a record of why you chose, and a head start on supplier qualification and validation.
What is inside
Seven tabs, one connected workbook.
Mandatory requirements
Mark the criteria a provider must pass, such as ISO 27001 scope, EU data location, document control and audit trails. A failed gate blocks qualification, even with a high score.
Verified scores only
A score earns points once you check it against a demo, document, test or reference, with a reviewer and date. Vendor claims stay visible as claims.
Full cost of ownership
Licences, support, implementation, migration, validation support, training and exit cost, compared over the horizon you choose.
Side by side
Up to 10 vendors with gate status, evidence coverage, weighted score, budget check and a qualified rank.
One worked vendor
A fictional vendor filled in end to end, so you can see how inputs become scores before you start your own.
How to use it
Each step matches a tab in the workbook.
Agree the rules first. Then score.
- Settings. Choose QMS, PLM or both, then set users, currency, budget, recovery targets and the minimum score.
- Vendors. Enter each provider once, with the exact product edition, hosting countries and contracting entity.
- Criteria. Review weights, scope and mandatory gates with your team before anyone scores a vendor.
- Evaluation. Score each criterion from 0 to 5, record gate decisions, and add the evidence, reviewer and review date.
- Costs. Enter comparable quotes, with explicit zeros for included fees. The dashboard updates itself.
Tips before you switch
A new QMS or PLM is a change to your quality system.
Run it through change control
Moving to a new QMS or PLM changes how your quality system works. Raise it as a change: describe it, assess the impact on procedures, records, training and open work, get it approved, and plan the transition.
Validate for your intended use
Validate the configured system for the way you will use it, before go-live and after significant changes. A vendor validation pack is useful input. The validation of your configuration is yours to own and sign.
Qualify the provider as a supplier
Record the evaluation, approval and planned re-evaluation under your purchasing controls. This workbook gives you the evaluation record to start from.
Plan migration and exit on day one
Confirm you can export complete records, attachments and audit history in usable formats, and agree how legacy records stay retrievable for their retention period.
Test with the people who will use it
Ask for sandbox access and run the same scripted tasks with your own team on every shortlisted system. Daily usability decides whether the records get kept.
Keep the evidence with the decision
Link every score to its demo, document or reference call. The completed workbook then becomes part of your documented selection decision.
A help sheet for your evaluation. This workbook gives you structure and a starting set of criteria. Adapt the criteria, weights and gates to your organisation, products and intended use. Compliance with ISO 13485, EU MDR and electronic-record requirements comes from how you select, validate and run the system, under your own change control. The example vendor, prices and scores are fictional.
Start with the worked example. Then assess your own.
References used in the workbook
ISO 13485 overview (ISO)
EU MDR (EU) 2017/745, Article 10(9)
FDA computer software assurance guidance
ISO/IEC 27001:2022 (ISO)