CITE at Makerere University supports innovators in Uganda and across Africa with device design, regulatory strategy, ISO‑ready quality systems, and pathways to CE Mark and local approvals.
Modular support across design, regulation, quality and testing – pick what you need now and grow into the full pathway as your device matures.
Human‑centred design, CAD, prototyping and verification planning that reflects African clinical workflows, infrastructure, and cost realities.
Outputs: design inputs & specs, CAD models, early risk file, prototype test plans.
Device classification, regulatory pathway mapping for Uganda, African NRAs and EU MDR, plus technical file preparation and notified‑body navigation.
Outputs: regulatory roadmap, standards list, CE Mark action plan.
Structured technical documentation, design history files, user manuals, IFUs and servicing guides written for real‑world African users.
Outputs: technical file sections, DHF structure, draft manuals and labelling content.
Hazard identification, FMEA, risk control and residual‑risk evaluation integrated into your design controls and post‑market plans.
Outputs: risk management plan, hazard analyses, risk reports.
Lean, right‑sized quality management systems for labs, SMEs and manufacturers aiming for ISO 13485 and MDR‑aligned processes.
Outputs: QMS blueprint, core SOPs, audit preparation checklist.
Guidance on bench, safety and usability testing, plus tailored trainings in design, regulation, risk and QMS for African teams.
Outputs: test plans, partner lab referrals, course outlines and certificates of participation.
Engage at any stage – from early concept sketches to regulatory submissions and manufacturing transfer.
We map your device concept, context of use, and constraints to identify the right mix of design, regulatory and quality actions.
Translate needs into design inputs, develop prototypes, and embed usability and risk thinking from the start.
Implement ISO 14971, design controls and QMS building blocks while drafting technical documentation.
Support testing, pilot deployments and submissions to regulators or notified bodies as required.
Plan for manufacturing transfer, post‑market surveillance and continuous improvement in African settings.
CITE works with start‑ups, clinicians, hospitals, universities, and manufacturers building solutions for theatres, ICUs, maternity wards, labs and beyond.
You have a concept, sketch or basic prototype and need help turning it into a robust, testable medical device aligned with regulatory expectations.
You need structured documentation, QMS processes, and clear regulatory pathways to move into pilots, registration and larger‑scale production.
Simple, high‑impact guides and templates that help African teams start building compliant processes before engaging expensive external consultants.
A short guide to classification, basic requirements, and where NDA, UNBS and other agencies fit.
Coming soon – downloadable brief.
Key SOPs and records small teams can adopt quickly to move towards an audit‑ready QMS.
Coming soon – SOP skeletons & checklists.
Outline structures for risk management plans, hazard logs and technical file contents.
Coming soon – editable templates.
Based at Makerere University College of Health Sciences in Kampala, CITE connects engineers, clinicians, regulators and manufacturers to grow an end‑to‑end medical device pipeline in Africa.
To enable safe, affordable, context‑appropriate medical devices to be designed, evaluated, certified and manufactured on the African continent.
CITE collaborates with universities, hospitals, regulators, manufacturers and development partners across Uganda, Africa and globally.
Share a brief description of your device, its stage, and what you need help with. The CITE team will propose a tailored support pathway.
Email: info@example-cite.ug
Phone / WhatsApp: +256 XXX XXX XXX
Location: CITE, College of Health Sciences, Makerere University, Kampala, Uganda.
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