Real results. Proven outcomes.

Software as a Medical Device (SaMD) for haemodialysis centres — storing comprehensive patient information including clinical conditions, dialysis procedures, prescriptions, and medications. The platform also handles patient visit scheduling and clinical staff shift management.

Create a complete QMS from scratch including all required SOPs and templates — while simultaneously assisting the Critical Supplier with technical documentation for MDR compliance. Coordinating between the device manufacturer and their development partner under strict regulatory standards.

We developed a comprehensive QMS framework aligned with ISO 13485 and MDR requirements, delivering all necessary SOPs and templates. Simultaneously, we worked closely with the Critical Supplier to ensure their technical documentation met regulatory standards — bridging the gap between development and compliance.

Innovative medical device assisting dental professionals in diagnosing and annotating X-ray images. The platform offers both manual and AI-assisted diagnostic capabilities, helping clinicians identify dental pathologies with greater accuracy and efficiency.

Assist the Legal Manufacturer with QMS implementation and technical documentation for UKCA licensing under MDR 2017/745 standards — while coordinating with three separate suppliers: a Critical Supplier for design and development, one for performance and security testing, and a third for QMS preparation.

We orchestrated a coordinated regulatory strategy across all three suppliers, ensuring their deliverables aligned with MDR requirements. We guided the Legal Manufacturer through QMS implementation while reviewing and approving technical documentation from each supplier, creating a cohesive submission package.

Comprehensive eHealth platform encompassing Electronic Medical Records (EMR), pharmacy and laboratory modules, Electronic Health Records (EHR), ePrescription system, and survey/questionnaire modules — designed to digitise and streamline healthcare delivery across Croatian healthcare institutions.

Ensure full compliance with Croatian national healthcare legislation and EU GDPR. The complexity of integrating multiple healthcare modules while maintaining data security and regulatory compliance required continuous oversight throughout the entire development lifecycle — from discovery through production.

As Compliance Officer, we supported the full project lifecycle. We worked closely with stakeholders to ensure all modules met Croatian healthcare regulations, participated in pre-production and production activities, and maintained continuous compliance oversight throughout development and deployment.

AI-powered SaMD providing continuous mood monitoring and clinical decision support for psychiatrists managing patients with depression and anxiety disorders. The platform uses validated behavioural biomarkers from patient-reported data and wearable inputs to generate risk scores and treatment adjustment recommendations.

Dual compliance with EU MDR 2017/745 (Class IIa) and the EU AI Act's high-risk AI provisions simultaneously. The team had strong ML expertise but no prior regulatory experience. Clinical evidence for AI-based mental health CDS required a non-traditional evidence strategy acceptable to both the Notified Body and ethics committees.

We built the QMS from scratch, aligned IEC 62304 documentation with the AI development lifecycle, and designed a clinical evaluation strategy using a prospective performance study alongside systematic literature review. We drafted the EU AI Act conformity assessment in parallel with the MDR technical file, ensuring zero duplication of effort across both regulatory frameworks.

Mobile SaMD enabling clinicians to capture standardised wound images and generate automated wound area measurements, tissue classification, and healing trajectory predictions. Used in hospital wound care units and community nursing settings across Germany and the UK.

The product held legacy MDD certification expiring in 2025. Transition to EU MDR required a complete rebuild of the technical file, a new Clinical Evaluation Report under MDCG 2020-1, and simultaneous UKCA submission — all within a 9-month window before the MDD certificate lapsed and market access was at risk.

We ran the MDD→MDR transition and UKCA certification in parallel. We rebuilt the clinical evaluation from scratch using a prospective PMCF study alongside systematic literature review, updated the risk management file to ISO 14971:2019, and rewrote the IEC 62304 documentation to cover all new software modules. Both submissions were lodged simultaneously.

Cloud-based SaMD that continuously analyses ECG data from wearable patches, detecting arrhythmias including atrial fibrillation, ventricular tachycardia, and bradycardia. The platform generates automated clinical alerts and transmits reports directly to cardiologists via the hospital information system.

EU MDR Class IIb certification for a high-acuity cardiac monitoring SaMD required a robust Clinical Evaluation Report and clinical performance study. Simultaneously, the team wanted to launch in Singapore and use the HSA approval as a gateway into Malaysia and Thailand — requiring careful documentation alignment across all regulatory frameworks.

We led the full EU MDR Class IIb technical file preparation, coordinating with a clinical research team on the performance study protocol. In parallel, we adapted the ASEAN CSDT submission for HSA Singapore using the MDR documentation as the foundation. Following HSA registration, we managed the Malaysia MDA Verification Route submission, completing it in under 3 months.

SaMD generating patient-specific 3D surgical plans from CT imaging for orthopaedic procedures including hip and knee arthroplasty and spinal fusion. The AI model segments bone anatomy, recommends implant sizing, and simulates surgical outcomes — giving surgeons a validated pre-operative plan before the patient enters theatre.

The product classified as EU MDR Class IIb due to surgical decision support for high-risk procedures. The NB required a prospective multi-centre clinical investigation in addition to the systematic literature review. The AI algorithm validation had to demonstrate performance on an independent validation cohort across multiple surgical centres.

We designed the clinical investigation protocol in collaboration with three European surgical centres and obtained ethics committee approval in Switzerland and Germany. We built the AI algorithm validation framework per IEC 62304 and the EU AI Act data governance requirements, and managed the complete technical file preparation including IEC 62366-1 usability engineering for surgeon-facing interfaces.

AI SaMD automating diabetic retinopathy screening from fundus photographs. The system grades retinal images across five severity levels, flags sight-threatening cases for urgent ophthalmologist review, and generates structured reports for integration into diabetic patient management pathways in primary care settings.

The team had excellent AI performance data from research settings but needed to translate it into regulatory-grade clinical evidence. Simultaneously they wanted to enter the Australian market using the EU MDR certification as the basis for TGA ARTG inclusion — requiring a unified clinical evaluation strategy acceptable to both regulators.

We designed a prospective real-world study in Polish primary care clinics combined with a systematic literature review, structured to meet both MDCG 2020-1 and TGA evidence expectations. For Australia, we prepared the ARTG inclusion application using the EU MDR NB certificate to qualify for the mandatory audit exemption — reducing TGA registration to under 4 months.