Build a lean, audit-ready QMS that accelerates EU MDR/IVDR and US FDA pathways. We design, implement, and optimize ISO 13485-based systems with integrated ISO 14971 risk, IEC 62304 software, IEC 62366-1 usability, and cybersecurity—for SaMD and Medical Devices.
EU & US coverage • Right-sized SOPs • Calm, predictable audits
Design and roll out ISO 13485-aligned processes with clear roles, records, and training.
Independent review against ISO 13485, QMSR alignment, MDR/IVDR elements, and MDSAP.
Qualify suppliers, maintain traceability, and stabilize production and acceptance activities.
Embed ISO 14971 across design, changes, complaints, and PMS.
Software lifecycle within the QMS for mobile, web, and cloud solutions.
Practical enablement that sticks—role-based, audit-proof.
Clinical ops/PMCF, penetration testing, and eQMS platform work are coordinated with vetted partners when needed.
We map every SOP and record to reviewer expectations to avoid documentation bloat.
| Deliverable | Purpose | Typical outputs |
|---|---|---|
| QMS blueprint | Define scope, processes, interactions | Process map, RACI, document tree |
| Core SOP set | Operate the system | Design control, Risk, Supplier, CAPA, Complaints, PMS, Training |
| Forms & records | Evidence of conformity | Templates with guidance & acceptance criteria |
| Internal audit pack | Verify effectiveness | Program, plans, checklists, reports, follow-up |
| Management review kit | Drive improvement | Agenda, inputs/outputs, metrics dashboard |
| QMSR/MDR mapping | Align with regulators | Trace matrix to ISO 13485 & regulatory clauses |
| eQMS playbook via partner | Digitize efficiently | Vendor shortlist, validation plan, migration checklist |
We help select the right eQMS and configure it to match your QMS—not the other way around.
Validation plan, test scripts, and controlled migration of documents and records.
Delivered with vetted partners; we oversee quality and integration.
Either. We prefer to keep what works, fill gaps to ISO 13485/QMSR, and simplify where possible.
Yes. We align your QMS to the MDSAP audit model and run internal audits to the same structure.
Yes. We integrate IEC 62304 and IEC 81001-5-1, including secure development, release, and maintenance.
Yes—role-based training with exercises, plus auditor coaching to keep audits calm and predictable.
Absolutely. We coordinate with your vendor or provide partner options, including validation support.
Book a free consultation. We’ll outline a practical QMS plan with dates, owners, and deliverables for your device portfolio.