For a Class IIa startup using Easy13485, typical IPP advisory costs for full MDR conformity are approximately 20,000 €. QMS structure and operation are covered by the Easy13485 Journey monthly fee (from 390 €/month), which replaces open-ended consulting retainers. Notified Body audit fees are not included — they vary by NB and device complexity. The calculator above shows your individual monthly figure.

Class I devices (most non-active, non-sterile, non-measuring) can be placed on the market via a self-declaration of conformity under MDR — no Notified Body audit required. Class IIa and higher require a Notified Body to audit your QMS and review your technical documentation before CE marking. The calculator shows which product line applies to your device class.

With Easy13485, teams have reached ISO 13485 certification for Class IIa devices in as little as 5 months from QMS setup. ISO 13485 certification covers the QMS — no product file or technical documentation is required at this stage. The MDR conformity assessment, including technical documentation and clinical evidence, follows separately. The Claim Check confirms a realistic timeline for your specific device and scope.

The Claim Check is a paid one-time entry assessment at 1,920 € (excl. VAT). It confirms whether Light, Essential or Certified fits your product, clarifies your intended use and risk class, and determines which Journey stage is the right starting point. The full amount is creditable against a booked Journey stage within 90 days.

Yes. Custom Made Devices (e.g. dental labs) and Extended Workbench / contract manufacturers have their own customer type in Easy13485. These enter directly at Operate & Scale — no Explore & Plan or Build phase required. The QMS covers supplier management, CAPA and Management Review at a reduced monthly rate from 290 €/month.

Yes. Clinical software, performance tools and other products requiring ISO 13485 QMS structure without medical device status have a dedicated Non-Medical Device track in Easy13485 Light. Risk-based development (Build, Verify & Document) and full QMS operation are available from 300 €/month.