Pricing

10X more affordable!

With over 70 documents required for certification, the traditional route can quickly become overwhelming and expensive.

A typical certification process starts at around €10,000 for the most basic documents (50 hours billed at €200/hour by a standard consultant), and overall costs can easily exceed €700,000—before factoring in operational expenses, salaries, product development, and testing.

Additional features often add to the cost:

Multiple parallel certifications: Additional €100,000 per high-risk device.
Custom market: Additional €50,000 per region (e.g., Africa, Middle East).
Tailored compliance: Additional 10%+ price increase for long-term support.

Our pricing, however, is up to ten times more affordable. It covers the entire certification process and provides a comprehensive view of your journey, saving you time and money. We consider it an essential investment in your success!

See the plans here.

We offer a base price based on your company size, plus variable pricing depending on additional features:

€ 500+ Monthly

Document management system
Basic support
Clinical resources
Quality assurance resources
5 team members
Risk class I device
Hardware device
Medical device
European Union certification
Shared server platform

€ 1,500+ Monthly

Document management system
Basic support
Clinical resources
Quality assurance resources
10 team members
Risk class I device
Hardware device
Medical device
European Union certification
Shared server platform

Popular

€ 5,000+ Monthly

Document management system
Basic support
Clinical resources
Quality assurance resources
15 team members
Risk class I device
Hardware device
Medical device
European Union certification
Shared server platform

Large company?

We also offer custom pricing for large companies, depending on the additional features chosen.

Where the price varies:

The additional features below can increase the price by up to 25% each:

Company size

The company size increases the number of team members who can collaborate. Large companies benefit from custom plans.

Risk class

Includes risk class I devices. Further options: risk classes II and III or comparable, depending on the certification market.

Device type

Includes hardware-only medical devices. Further options beyond hardware: software devices and cloud software devices.

Support level

Includes basic human support. Further options: premium support, expert support, and 24/7 support.

Resources

Includes clinical and quality assurance. Extras: regulatory, research, development, project management, and post-market.

Team members

Includes up to 5 team members. Further options: up to 20, up to 100, and above 100 team members.

Device categories

Includes the certification for one device category. Further options: up to four device categories.

Markets served

Includes the certification for the European Union. Further options: United States, Canada, and beyond.

Hosting platform

Includes on-premise shared hosting. Further options: individual server, shared cloud, and individual cloud hosting.

Our pricing factors:

We offer a base price based on company size, plus variable pricing depending on additional services.

Estimate a price for your device!

Prices are indicative, exclude VAT, and refer to one month of Medflow.

Company size

Units to certify

Risk class

Device type

Human support level

Resource access

Number of team members

Number of device categories

Number of markets served:

Hosting platform

Total price: € 0 / month.

Flexible price for exceptional value.

We offer a base price based on your company size, plus variable pricing depending on additional services.

Four examples of what you get for your money:

Micro

A micro company with 9 employees (5 team members) wants to certify 100 units of a hardware medical device with risk class I in the European Union. They use clinical and quality assurance certification with basic human support on the on-premise shared version of Medflow.
Total cost: € 500.

Small

A small company with 50 employees (15 team members) aims to certify 500 units of a hardware and software medical and in-vitro device with risk class II in the EU and the US. They utilize clinical, quality assurance, and regulatory certification with premium human support on the on-premise individual version of Medflow.
Total cost: € 2.559.

Medium

A medium-sized company with 250 employees (100 team members) wants to certify 500 units of a hardware and software device with three categories of risk class II in the EU, US, and Canada. They use clinical, quality assurance, regulatory, R&D, and project management certification with expert human support on the cloud shared version of Medflow.
Total cost: € 11.230.

Large

A large company with 1,000 employees (100 team members) seeks to certify 5,000 units of a hardware and software device with four categories of risk class III in multiple regions including the EU, US, and Canada. They utilize clinical, quality assurance, regulatory, R&D, project management, and post-market surveillance certification resources with expert 24/7 human support on the cloud individual version of Medflow.
Total cost: € 79.649.

Pricing

10X more affordable!

See the plans here.

Micro

Small

Medium

Large company?

Where the price varies:

Company size

Risk class

Device type

Support level

Resources

Team members

Device categories

Markets served

Hosting platform

Our pricing factors:

Estimate a price for your device!

Flexible price for exceptional value.

Micro

Small

Medium

Large

Get started:

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