Doctor explaining a medical device to a patient

For medical device manufacturers, specialist retail & service

MDR documentation, hospital tenders, safety check deadlines. How much time is left for innovation?

ivato digitalises the processes around your product: tenders and hospital sales, user training, service and safety checks, complaints and post-market surveillance, technical documentation and audits. Your ERP and QM system stay, and regulatory responsibility stays with you. Your team gains time for products and customers.

Callback from an industry adviser →View the product lifecycle ↓

Clients from this industry

Your day-to-day

Do you recognise these sentences from RA/QM, sales and service?

In medical technology, the documentation workload grows faster than the team. At the same time, hospitals demand faster quotations, complete evidence and reliable service. A large part of the time goes into searching, reconciling and updating. That is exactly where we start.

You recognise 0 of 8 statements

Tap the statements you recognise from your day-to-day work.

The pattern behind it: Highly qualified specialists spend time maintaining documents and lists instead of working on products and customers.

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Product lifecycle

At which point in the product lifecycle does your team lose the most time?

Click on a stage. You will see how it works in many medical technology companies today, what ivato implements there and what changes as a result. Usually two to four stages have the greatest leverage. Which ones they are for you, we clarify in the initial call.

Today

Tenders found by chance

Hospital tenders are published on various platforms. They are searched for when there is time, often too late. Knowledge about replacement cycles sits with field sales.

With ivato

Tender radar and hospital CRM

  • Daily search for suitable tenders
  • AI assesses fit and summarises requirements
  • Hospitals, purchasing groups and installed bases in the CRM

What changes

No missed opportunity

Your sales team sees suitable tenders early and knows where replacement demand will arise in the coming years.

Descriptions show typical processes. Regulatory assessments, reporting decisions and approvals stay with the responsible persons in your company.

Case examples

What does this look like in practice in a medical technology company like yours?

Four examples from manufacturing, service and specialist retail, each with starting point, solution, result and calculation. What they all have in common: ERP and QM system stayed in place, the software used was documented for QM use, and after 8 to 12 weeks the solution was running in day-to-day work.

  • ManufacturerBaden-Württemberg70 employeesClass IIa products

    Complaints captured in a structured way, PMS report as a draft

    Starting point
    Complaints came via field sales, hotline and email. Capture was inconsistent, and trend analysis for post-market surveillance was done by hand from several sources.
    Solution
    Uniform complaint capture with mandatory fields, notice of possible vigilance relevance for review, linked to batch and UDI, trend analysis and draft of the PMS report.
    Result
    Complete data, deadlines in view, PMS report in days instead of weeks. Assessment and reporting decision stay with QM.
    Investment
    €34,000
    Payback
    9 months

  • Medical technology serviceSaxony45 employeesHospitals, MVZ, practices

    Safety checks and maintenance for thousands of devices without an Excel list

    Starting point
    Customers' installed base and inspection deadlines in Excel, appointments arranged by phone, inspection records on paper, evidence hard to retrieve for customers.
    Solution
    Device database per customer with inspection deadlines, automatic appointment proposals, technician app with inspection record and photos, customer portal with all evidence.
    Result
    No deadline slips, technicians are better utilised, hospitals find evidence themselves.
    Investment
    €38,000
    Funding
    €15,200
    Own contribution
    €22,800
    Payback
    8 months

  • Specialist retailNRW30 employeesHospital and practice supplies

    Tenders spotted early, quotations finished faster

    Starting point
    Hospital tenders were found by chance or late. Qualification evidence, product data sheets and prices were assembled anew for every quotation.
    Solution
    Daily search for suitable tenders, AI assesses fit and requirements, quotation file with evidence and data sheets prepared, CRM for hospitals and purchasing groups.
    Result
    More tenders processed, no missed deadlines, field sales knowledge in the CRM instead of in people's heads.
    Investment
    €26,000
    Funding
    €10,400
    Own contribution
    €15,600
    Payback
    7 months

  • ManufacturerBavaria120 employeesProduct families class I to IIb

    Changes in technical documentation traceable and consistent

    Starting point
    Every product or standards change triggered adjustments in many documents. Cross-references were checked by hand, and audits tied up the RA team for weeks.
    Solution
    AI finds affected documents and passages when changes occur, proposes adjustments as drafts, checks cross-references, audit evidence findable by asking a question. Approval within the existing document control process.
    Result
    Less searching, more consistent documentation, more relaxed audits. The RA team works on assessment instead of formatting.
    Investment
    €46,000
    Payback
    10 months

More case studies from Healthcare & care · Funding programmes

Solutions

Which tools does ivato use in medical technology?

Proven building blocks, adapted to your products, your processes and your QM system. We do not develop medical device software, but digitalise sales, service and documentation around your product. Assessments and approvals stay with your responsible persons.

  • Tender radar & hospital CRM

    Suitable tenders found and assessed daily, quotation file prepared, hospitals, purchasing groups and replacement cycles in the CRM.

    To Sales & CRM automation →

  • Devices, safety checks & service

    Installed base per customer with inspection deadlines, automatic appointment proposals, technician app with inspection record, customer portal with evidence.

    To Reducing cost pressure →

  • Digital user training

    Training with checklist, digital signature and storage in the device record. Evidence retrievable for operators at any time.

    To Implementation →

  • Complaints, CAPA & PMS

    Uniform capture, linked to batch and UDI, notice of possible vigilance relevance for review, trend analysis and report drafts.

    To Strategy →

  • Technical documentation assistant

    Finds affected documents when changes occur, proposes adjustments as drafts, checks cross-references and consistency, supports translations.

    To Scaling with AI →

  • Audit preparation

    Evidence, records and CAPA history findable by asking a question, checklists for internal and external audits, open points with owners.

    To Securing succession →

Systems & validation

Do we have to replace our ERP or QM system, and what about validation?

No, ERP, QM system and document control remain the lead systems. We start alongside them: sales, service, data capture and drafts. Software used in a QM context must be validated for its intended use in accordance with ISO 13485. We provide the description of purpose, risks and tests so that your QM can carry out and document the validation.

Your systems stay

  • Connection to common ERP, CRM and QM systems via interfaces or exports
  • Documentation for software validation in the QMS
  • Roles, approvals and change log traceable
  • Data stays on servers in Germany
MDR2027 · 2028

Are you using the extended MDR transition periods to digitalise documentation and processes?

The transition periods for legacy products under the Medical Device Regulation have been extended, depending on risk class, until the end of 2027 or the end of 2028, subject to conditions. The time until then is short if technical documentation, PMS and complaint management are still based on paper and Excel. Digital processes create capacity for the actual work on the dossier.

As of: 10/2026 · simplified presentation, not legal or regulatory advice, check deadlines and conditions case by case

Clarify in a conversation ↓

Process & prices

How do we start without endangering audits and approval projects?

With a 30-minute conversation. After that you decide step by step. Your effort is a few meetings with management, RA/QM, sales and service. We align the schedule with your audits and submissions.

  1. Step 1

    Initial call

    30 minutes with an adviser who knows medical technology companies. We discuss where things get stuck, and tell you honestly whether and where digitalisation pays off.

    free of charge

    Request a callback ↓

  2. Step 2

    Strategy

    We look at sales, service and QM processes, calculate the business case in euros and hours and agree a roadmap, including validation needs.

    Fixed price by scope · eligible for funding

    To Strategy →

  3. Step 3

    Implementation

    We implement the most effective building blocks, connect your systems, deliver the validation documents and train your team.

    from €20,000 net · 8–12 weeks

    To Implementation →

Estimate your funding

Funding rate
Funding
€12,000
Your contribution
€18,000

Simplified calculation. Rate and maximum amounts depend on the programme, federal state and company size. Consulting can additionally receive a grant of up to €5,600.

Projects successfully supported
1,000+
Projects successfully supported
Years of experience with mid-sized companies
25+
Years of experience with mid-sized companies
Funding for implementation
up to 60%
Funding for implementation
dedicated contact person on the project
1
dedicated contact person on the project

Frequently asked questions

What management and RA/QM want to know beforehand

Your question is not here? In the initial conversation we take 30 minutes for your specific topic.

As a tool, yes; as the responsible party, no. The AI finds affected passages, proposes wording and checks consistency. Content, assessment and approval stay with your responsible persons and run through your existing document control.

We describe the intended use, risks and test cases of the software used and support its execution. Your QM assesses, carries out the validation and documents it in the QMS. The effort depends on the risk of the intended use.

No. We digitalise sales, service, QM processes and documentation around your products. Software that is itself a medical device is not part of our scope of services.

Complaints can contain health data. This is particularly well protected, captured only as far as necessary and processed with clear roles and access rights. AI services do not use your data to train third-party models.

Often precisely then, because RA, QM and service depend on a few people. If a building block saves weeks before an audit or wins one more tender, it pays off quickly. The business case shows this before the investment.

For consulting, a grant of up to €5,600 is possible, and for implementation up to 60% depending on federal state and programme. We check the suitable programmes in the initial call and take care of the application documents. As of: 10/2026, programmes change regularly.

Read on

Contact

Exchange ideas with one of our specialists from your industry.

30 minutes, free of charge. You describe where things get stuck, and we tell you openly which two or three areas are worthwhile for you and roughly what that costs.

  • Callback within one working day
  • Schedule aligned with audits and submissions
  • Confidential, NDA on request

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