The verdict in three sentences
A good requirements document for dental lab software runs to 15 to 25 pages and holds 20 to 35 prioritised functional requirements, each with a measurable acceptance test. Its core is the full life of a case: receiving the intraoral scan, production, material lot traceability and the custom device statement, then delivery and invoicing. With a document of that quality, vendor quotes become comparable and the gap between EUR 40,000 and 130,000 can be explained line by line.
Context to describe in part one
The owner of a Berlin lab with 30 dental technicians serves 180 practices across Berlin and Brandenburg. Most cases now arrive as digital impressions through scanner manufacturer platforms (3Shape, Medit, iTero and others). Every crown or bridge is a custom made device under the EU Medical Device Regulation 2017/745 and the German MPDG, so the lab must issue a statement for each case and trace the material lots used. Invoices to practices must follow BEL II for statutory insured patients and the BEB catalogue for private work.
| Context data to fill in | Illustrative example | Why the vendor needs it |
|---|---|---|
| Cases a day | 100 to 280 (here 190) | Sizing tracking screens and hosting |
| Active client practices | 180 | Portal and account volume |
| Share of digital impressions | 65 to 85% | Priority of automatic import |
| Production steps | 6 to 12 per case type | Modelling tracking by workstation |
| Traced materials | 50 to 130 items with lots | Traceability and possible recalls |
| Current tools | legacy lab software, spreadsheets, CAD | Migration and interfaces |
| Target budget | EUR 40,000 to 130,000 (market) | Trade offs between priorities |
The template, ready to fill
| Section | Expected content | Pages |
|---|---|---|
| 1. Context and goals | Key figures above, no more than three measurable goals | 2 |
| 2. Scope | What is in, what is out (CAD, accounting) | 1 |
| 3. Life of a case | Diagram from receipt to invoice | 2 to 3 |
| 4. Functional requirements | 20 to 35 prioritised items (see next table) | 5 to 8 |
| 5. Regulatory requirements | Custom device statement, traceability, document retention | 1 to 2 |
| 6. Technical requirements | Hosting in Germany or the EU, backups, accounts, security, interfaces | 2 |
| 7. Data migration | Practices, price lists, case history | 1 |
| 8. Terms | Schedule, acceptance testing, exit, maintenance, response format | 2 |
Functional requirements, prioritised and measurable
An extract, rated Must, Should or Could. Every criterion must be testable at acceptance.
| No. | Requirement | Priority | Measurable criterion |
|---|---|---|---|
| F01 | Automatic import of intraoral scans from scanner platforms | Must | Case created with no rekeying within 5 minutes of the practice sending it |
| F04 | Tracking by production step and technician | Must | Status visible to the practice in real time, 100% of steps time stamped |
| F07 | Material lots captured by barcode scan | Must | Under 10 seconds per material, no case can close without lots |
| F09 | Custom device statement generated per case | Must | Document generated at close, archived and attached to the delivery note |
| F12 | Reverse search by material lot | Must | List of affected cases and practices in under 30 seconds |
| F15 | Practice portal: orders, tracking, documents | Should | 80% of active practices connected after 6 months |
| F18 | BEL II and BEB invoice lines per case | Should | Monthly invoices for 180 practices generated in under one hour |
| F22 | Delivery route planning | Should | Route sheet ready on mobile every morning before 7:30 |
| F27 | Workload dashboard by workstation | Could | Next 5 days of load visible to the lab manager |
| F31 | Practice and lab messaging attached to the case | Could | 100% of messages archived with the case |
Regulatory requirements should point to MDR 2017/745 and the MPDG rather than interpret them: ask vendors to show how the software produces and retains the documentation, with responsibility for content staying with the lab. Personal data on patients falls under GDPR and the BDSG.
As a 2026 market ballpark, budgets run from EUR 40,000 for order tracking with basic traceability to EUR 130,000 with a practice portal, delivery routes and full BEL II invoicing. For a nearshore comparison, Kolonell's prices are 6,100 to 10,670 EUR (4,000,000 to 7,000,000 FCFA) for a medium complexity custom application and 10,670 to 22,870 EUR and more (7,000,000 to 15,000,000 FCFA and more) for a complex one, with Standard maintenance at 114 EUR (75,000 FCFA) a month; German interface texts and EU hosting are part of the scope.
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Illustrative example: Jan, owner of a Berlin lab with 30 technicians, handles 190 cases a day. Office staff spend about 3.5 minutes per case rekeying the scan details, lots and device statement, around 11 hours a day. Cutting that to 1 minute saves 7.9 hours a day, roughly 1,740 hours a year over 220 days, worth EUR 69,600 at EUR 40 an hour loaded. For a project budgeted at EUR 85,000, payback comes in about 15 months, before counting fewer status calls from practices.
FAQ
How much does custom dental lab software cost in Berlin?
The 2026 market ballpark runs from EUR 40,000 to 130,000 depending on scope. Order tracking with traceability and device statements usually sits between EUR 40,000 and 70,000.
How many requirements should the document contain?
Aim for 20 to 35 functional requirements, about ten of them Must. Beyond 50, quotes get hard to compare and scope creeps.
Should the software produce the custom device statement?
It should generate and archive it for each case from captured data, while the lab stays responsible for its content under MDR 2017/745. A good tool saves 2 to 3 minutes of typing per case.
Can scans be pulled automatically from intraoral scanner platforms?
Yes, most manufacturer platforms allow file exchange, with varying access terms. Check it for your 3 or 4 main platforms during discovery.
How long will the project take?
Plan 4 to 7 months, including 3 to 4 weeks to finish the requirements and a pilot with 10 to 15 practices before opening the portal to all.
Let's scope your project. Send us your completed template or your case, practice and material volumes, and we will review it and price a realistic scope. Detailed quote within 48 h. WhatsApp +221 77 596 93 33.
Mohamed Bah
Fondateur, Kolonell
Passionate about digital and entrepreneurship in Africa, Mohamed has been helping Sénégalese businesses with their digital transformation since 2020. Founder of Kolonell, he believes every SME deserves a professional and accessible online présence.
