Answers to the most common questions about medical software certification.
How much does medical software certification cost?
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Costs depend on the service scope and device complexity. A documentation audit starts from €5,000. Full EU MDR certification support ranges from €10,000 to €25,000. ISO 13485 QMS implementation typically ranges from €8,000 to €18,000. We provide a fixed-price proposal after the free discovery call — no surprises.
How long does medical software certification take?
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Timelines vary based on device class, existing documentation, and regulatory pathway. Typical timelines: Documentation audit — 1–4 weeks; Full MDR certification — 6–9 months; QMS implementation — 3–6 months. We provide a precise timeline estimate after the initial discovery session.
Do I need a Notified Body for EU MDR certification?
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It depends on your device class. Class I non-sterile, non-measuring devices can self-declare conformity without a Notified Body. Class IIa, IIb, and III devices require Notified Body involvement. We help you determine the correct classification and, where needed, select and manage the relationship with a suitable Notified Body.
What's the difference between MDR and UKCA certification?
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EU MDR applies to the European Union market, while UKCA applies to Great Britain (England, Scotland, Wales). Northern Ireland follows EU MDR. The requirements are similar but have key differences in timelines, notified/approved bodies, and specific documentation requirements. Many companies pursue both for full market access.
Do you work with AI/ML medical devices?
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Yes, we specialize in AI/ML medical devices (AIMD). We address specific challenges including algorithm validation, clinical evaluation for AI, cybersecurity, change management for continuous learning models, and compliance with emerging AI regulations like the EU AI Act.
Can you help with legacy device recertification?
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Yes, we assist with transitioning legacy devices from MDD to MDR. This involves gap analysis, documentation updates, clinical evaluation updates, and technical documentation restructuring to meet MDR 2017/745 requirements before the applicable deadlines.
Do you provide ongoing post-certification support?
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Yes. Certification is not a one-time event — regulations require ongoing post-market surveillance, periodic safety update reports (PSURs), and QMS maintenance. We offer retainer-based regulatory support to keep your documentation current and your QMS audit-ready year-round.