Turn engineering work into regulatory-ready evidence.
Rajan Solutions helps medical device startups bridge engineering, QMS, risk, V&V and regulatory documentation — so your team knows what to document, when to document it, and how to avoid expensive late-stage rework across AU, US and EU pathways.
Practical support for teams building regulated devices.
Lean, implementation-focused support for startups that need the right level of structure without becoming slow or overburdened. Engage on a single gap or across the whole picture.
Intended use & classification
Intended use and claims review, classification support, and standards applicability mapping for AU, US and EU pathways.
QMS & design controls
Practical QMS roadmap, design control setup, supplier quality, CAPA and change control aligned to ISO 13485 principles.
Risk management file
Set up ISO 14971-style risk files and connect risk controls to design, verification and usability activity.
Software lifecycle planning
Plan IEC 62304-aligned software lifecycle evidence for firmware, apps, cloud-connected systems and SaMD, with usability (IEC 62366-1) where it applies.
V&V and traceability
Build pragmatic verification and validation plans, matrices and evidence structures that link back to design inputs.
Technical file & audit support
Review records, run gap assessments, facilitate design reviews and prepare technical files / design history files for the conversations ahead.
Devices we've supported.
Selected programmes across wearable, infusion, monitoring, ablation, telehealth and connected systems, spanning Australian, US and European markets.
Wearable ECG monitor
Wearable electrocardiogram monitoring device.
Syringe infusion pump
Syringe-driver infusion delivery system.
Volumetric infusion pump
Large-volume infusion delivery system.
Skin treatment equipment
Energy-based aesthetic / dermatological device.
Baby HR & SpO₂ monitor
Infant heart-rate and pulse-oximetry monitor.
Prostate ablation device
Minimally invasive prostate ablation system.
Telehealth data acquisition system
Connected telehealth physiological data acquisition system.
Hormone tracking system
Connected hormone-tracking platform (software as a medical device).
Classification-aware support across device, software and evidence planning.
Support is tailored around intended use, claims, software role, use environment, risk profile and target markets — helping teams define the right process and evidence expectations early. Focus is on Class I, IIa and IIb devices, not Class III.
Australia (TGA)
European Union (EU MDR)
United States (FDA)
Software (IEC 62304)
Set up the process, help the team use it, then step back until needed.
Rajan Solutions is designed for startup teams that need targeted process and project support, not permanent dependency.
Assess
Understand the product, intended use, current evidence, target markets and immediate gaps.
Define
Set up the right processes, templates, ownership and review points for the stage of the company.
Embed
Help the team apply the process during real development work, reviews, changes and V&V planning.
Return
Step back and come in for audits, design reviews, readiness checks or targeted support as needed.
Scope of support. Rajan Solutions provides process definition, project support, readiness review, gap assessment, planning, templates and advisory support. It does not certify, approve or submit devices on behalf of manufacturers, does not guarantee regulatory clearance or approval, and does not replace a manufacturer's own regulatory responsibilities.
Start with where your product and process currently are.
Share the device type, intended use, target markets and where the process gaps feel most urgent.