# Sted vs Qualio

For medical device startups building ISO 13485: Qualio is a life-sciences eQMS; Sted adds ISO 27001, GDPR and Cyber Essentials in one system.

Source: https://sted.digital/docs/compare/sted-vs-qualio · Last reviewed 18 October 2026 · Strand Sted compared

Choose Qualio if you need a life-sciences eQMS with document control, training and supplier quality on every plan (source 2). Choose Sted if your device startup also needs ISO 27001, GDPR and Cyber Essentials in the same system, wants each device classified per market, and wants a published price.

## Who each is for

Qualio is a cloud eQMS for life sciences. Its Foundation plan is for teams formalising quality management for the first time and preparing a first regulatory submission; Growth is for companies working across several markets and frameworks (source 2). It suits a device company whose main job is the quality system, on an annual contract with an implementation project.

Greenlight Guru sells quality and clinical solutions for medical device companies through its sales team (source 3). Formwork, from OpenRegulatory, is an eQMS with a free Community Edition and paid monthly plans (source 4).

Sted is for a medical device or digital health startup of a few people that must build ISO 13485 for EU MDR or UKCA and, at the same time, answer hospital customers on ISO 27001, GDPR and Cyber Essentials. One catalogue of 85 standards, regulations and schemes covers both sides, and Sted recommends which apply to you and why.

## Where Qualio is stronger

- A product built only for life sciences. Qualio's plans are written for teams preparing regulatory submissions, and every plan includes document control, training management and supplier quality management (source 2).
- Quality events with ready templates. Qualio includes five quality event templates on Foundation and an unlimited number on Growth (source 2).
- Life-sciences frameworks in one subscription. Qualio includes three frameworks on Foundation and five on Growth, from FDA, MDR, ISO and GxP (source 2).
- Its own certification record. Qualio states it is ISO 27001 certified and shows an ISO 9001 badge on its pricing page (source 2).
- A known implementation path. Qualio says most customers are live within 30 to 60 days (source 2).
- Review base. Qualio has about 730 reviews on G2, averaging 4.4 stars (source 5).

## Where Sted is stronger

- Both sides of a device startup's obligations in one catalogue. Sted's catalogue holds 85 standards, regulations and schemes across eight assurance areas, so ISO 13485, EU MDR and UK MDR 2002 sit beside ISO 27001, GDPR, Cyber Essentials, AI governance and NHS digital health schemes in one system.
- Recommendations with reasons. Sted recommends the standards that apply to you or would help, including ones you had not asked about, and explains why for each one.
- Device classification per market. Sted classifies a medical device for the EU and Northern Ireland under EU MDR, Great Britain under UK MDR 2002, Canada under the Medical Devices Regulations (SOR/98-282), Australia under the Therapeutic Goods (Medical Devices) Regulations 2002 and the United States, and shows the regulation, class and rule with its reasoning. Its rules decide, not the AI model, and the result is information for you and your notified body or regulator to check, not a verdict.
- Device documents that fit your other standards. For ISO 13485 Sted's knowledge base carries 23 policies and procedures and 60 record templates tagged to its clauses, and for EU MDR it adds procedures and records for post-market surveillance, PSURs and incidents. Sted drafts one framework from it for every standard you choose, adapted to your organisation, and each recommended requirement names the standards it helps you meet.
- Changes at no extra cost. Plans meter seats and features, never standards: on a paid plan you change your profile, add devices and other products, add as many standards and regulations as you like and regenerate, at no extra cost.
- A knowledge base Sted maintains. Sted maintains the standards, regulations and best practice in its knowledge base. When its recommendations for a document you have worked on change, it prepares an updated draft beside your version at no extra cost, and you accept or decline each change.
- Records and training that keep running. Records follow templates with structured fields, including a corrective and preventive action record, and a record type can repeat with a task raised when it falls due. Training is completed against each approved version. Records are part of the Full Management System plan.
- A published price and London hosting. Sted publishes every plan's price, and your data is stored in AWS London.

## Side by side

Sted beside Qualio and Greenlight Guru. Every competitor cell is dated and numbered to the page it comes from; "Not listed" means the page does not name it, not that the product lacks it. Formwork is left out of the table because its pricing page could not be read for this review.

| Dimension | Sted | Qualio | Greenlight Guru |
|---|---|---|---|
| Published price | £99, £299 or £499 a month, or £950, £2,870 or £4,790 a year, ex VAT (checked 18 October 2026, source 1) | Not listed on Qualio, Pricing (checked 18 October 2026, source 2) | Not listed on Greenlight Guru, Pricing and packages of the MedTech Suite (checked 18 October 2026, source 3) |
| Pricing unit | One flat monthly or annual price per plan, for 1, 5 or 15 users. | Annual subscription per plan, with 5 or 10 edit users, 3 or 5 frameworks and unlimited basic users (checked 18 October 2026, source 2) | Priced by solution, Quality or Clinical, through its sales team (checked 18 October 2026, source 3) |
| Audit included | Booked and paid separately, with a notified body, approved body or certification body; Sted prepares the evidence it will ask for. | Not listed on Qualio, Pricing (checked 18 October 2026, source 2) | Not listed on Greenlight Guru, Pricing and packages of the MedTech Suite (checked 18 October 2026, source 3) |
| How scope and applicability are decided | Sted recommends what applies from your answers and explains why; its rules decide, not the AI model. | You choose frameworks; AI gap analysis maps your documents to controls (checked 18 October 2026, source 2) | Not listed on Greenlight Guru, Pricing and packages of the MedTech Suite (checked 18 October 2026, source 3) |
| Standards covered | 85 standards, regulations and schemes across eight assurance areas. | FDA, MDR, ISO and GxP, as named on the pricing page (checked 18 October 2026, source 2) | ISO 14971 risk and EU MDR clinical follow-up named in its product descriptions (checked 18 October 2026, source 3) |
| ISO 13485 and EU MDR | Both in the catalogue; Sted classifies a device per market with the regulation, class and rule, for you and your notified body or regulator to check. | MDR named; ISO 13485 not named on the pricing page (checked 18 October 2026, source 2) | EU MDR named for clinical follow-up; ISO 13485 appears as a guide link (checked 18 October 2026, source 3) |
| Cyber Essentials | In the catalogue, with 8 policies and 11 record templates mapped to the five technical controls. | Not listed on Qualio, Pricing (checked 18 October 2026, source 2) | Not listed on Greenlight Guru, Pricing and packages of the MedTech Suite (checked 18 October 2026, source 3) |
| Policy drafting | Sted drafts your policies and procedures from its knowledge base, adapted to your organisation, for you to review. | Document control on every plan, with Qualio Copilot (checked 18 October 2026, source 2) | Document control with traceability for documents, training and change (checked 18 October 2026, source 3) |
| Risk register | Risks and opportunities is one of the management-system registers administrators keep, with risk levels computed from likelihood and impact. | Not listed on Qualio, Pricing (checked 18 October 2026, source 2) | ISO 14971 risk assessment as requirements and tests change (checked 18 October 2026, source 3) |
| Training records | Training is completed against each approved version; a new version asks people to train again. | Yes (checked 18 October 2026, source 2) | Yes (checked 18 October 2026, source 3) |
| Hosting region | AWS London (eu-west-2). | Not listed on Qualio, Pricing (checked 18 October 2026, source 2) | Not listed on Greenlight Guru, Pricing and packages of the MedTech Suite (checked 18 October 2026, source 3) |
| Human expert included | Software with support behind it; no consultant or success manager comes with a plan. | Implementation fee on every plan, with an onboarding team to go-live (checked 18 October 2026, source 2) | Not listed on Greenlight Guru, Pricing and packages of the MedTech Suite (checked 18 October 2026, source 3) |

## Pricing as published

Sted publishes the monthly and annual price of every plan, excluding VAT (source 1).

Qualio publishes no amounts: each plan is an annual subscription quoted on request, and an implementation fee applies to all plans (source 2). Greenlight Guru routes pricing for its Quality and Clinical solutions through its sales team (source 3). Formwork lists a free Community Edition and paid monthly plans on its pricing page (source 4). SelectHub, a software directory, gives a starting yearly figure for Qualio without saying where it comes from or what it buys (source 6); that is third-party data, not a price Qualio publishes.

## Using them together or switching

Running both can make sense. Some device startups keep an eQMS for design and production records and still need ISO 27001 and GDPR for hospital procurement. Agree which system owns each record type and each shared policy, such as document control or supplier approval, so the same policy is not approved twice.

Moving from an eQMS to Sted means bringing your approved procedures, your training records and your supplier approvals. Sted drafts its documents from the knowledge base for you to review against what you already have approved. A validated history, with its signatures and audit trail, stays in the system that created it, so export and archive it before you leave.

Tell your notified body or approved body before the next audit. It assesses conformity; Sted prepares the evidence it will ask for. For the standards, read the [ISO 13485 hub](/docs/standards/iso-13485), the [EU MDR hub](/docs/standards/eu-mdr) and the [UK MDR 2002 hub](/docs/standards/uk-mdr-2002). For the work, see [how Sted decides what applies](/docs/product/classification-and-applicability), the [document control guide](/docs/guides/document-control) and the [CAPA and root-cause guide](/docs/guides/capa-root-cause-analysis). The security platforms are in the [compliance automation platforms comparison](/docs/compare/compliance-automation-platforms), and consultants and toolkits in [Sted vs a consultant or DIY templates](/docs/compare/sted-vs-consultant-or-templates).

## Frequently asked questions

Q: What is a Qualio alternative for a medical device startup?
A: Sted is one, if your startup needs ISO 27001, GDPR and Cyber Essentials alongside ISO 13485 and EU MDR. Greenlight Guru (source 3) and Formwork (source 4) are eQMS products for medical device companies. Choose by whether your main job is the device quality system alone or the quality system plus the security and privacy evidence hospital customers ask for.

Q: How much does Qualio cost?
A: Qualio doesn't publish a price. Every plan is an annual subscription quoted on request, and an implementation fee applies to all plans (source 2). A software directory gives a starting figure without saying what it buys (source 6), so ask Qualio for a written quote that names the frameworks, edit users and implementation fee.

Q: What is the right ISO 13485 QMS software for a startup?
A: The one that matches who does the work and what else you must prove. An eQMS such as Qualio is built for life-sciences quality management. Sted drafts your ISO 13485 procedures from its knowledge base, keeps your records on its record templates, and holds both beside ISO 27001 and GDPR, at a published monthly price.

Q: Is there an eQMS for a medical device startup in the UK?
A: Yes. Qualio, Greenlight Guru and Formwork all sell to device companies; Qualio and Greenlight Guru state no hosting region on their pricing pages (sources 2, 3). Sted holds your data in AWS London and classifies a device for Great Britain under UK MDR 2002 as well as for the EU.

Q: What EU MDR compliance software suits a small company?
A: Software that holds your quality system, post-market surveillance and vigilance records, and helps you work out your device's class. Sted classifies a device per market with the regulation, class and rule, for you and your notified body or regulator to check, and its knowledge base carries record templates for post-market surveillance plans, PSURs and incidents.

Q: Does adding a device or a standard in Sted cost more?
A: No. Sted's plans meter seats and features, never standards: on a paid plan you can change your profile, add devices and other products, add as many standards and regulations as you like and regenerate, at no extra cost. Sted classifies each medical device per market, with the regulation, class and rule.

Q: Who keeps the procedures up to date in Sted?
A: Sted maintains the standards, regulations and best practice in its knowledge base. When its recommendations for a document you have worked on change, Sted prepares an updated draft beside your version at no extra cost, and you accept or decline each change.

Q: How do Qualio, Greenlight Guru and Formwork compare on price?
A: Only Formwork lists prices on its own site: a free Community Edition and paid monthly plans (source 4). Qualio quotes an annual subscription with an implementation fee, and Greenlight Guru routes pricing through its sales team (sources 2, 3). This page doesn't rank them.

## Sources

1. StedOS pricing: https://sted.digital/pricing (checked 18 October 2026)
2. Qualio, Pricing: https://www.qualio.com/pricing (checked 18 October 2026)
3. Greenlight Guru, Pricing and packages of the MedTech Suite: https://www.greenlight.guru/pricing (checked 18 October 2026)
4. OpenRegulatory, Formwork pricing: https://openregulatory.com/formwork/pricing (checked 17 October 2026)
5. G2, Qualio reviews: https://www.g2.com/products/qualio/reviews (checked 17 October 2026)
6. SelectHub, Qualio vs Greenlight Guru (software directory): https://www.selecthub.com/quality-management-software/qualio-vs-greenlight-guru/ (checked 18 October 2026)