Regulatory & quality systems engineering
NUREG Solutions builds the regulatory intelligence layer, quality management system and submission engineering that medical device, in-vitro diagnostic and health-tech teams need to register, certify and defend — across India, the EU and the United States.
01 — Capabilities
Every engagement produces artefacts an auditor can read — not slides, not assurances, but a defensible, versioned file.
Continuous monitoring of CDSCO, EU and FDA rule changes, translated into a prioritised, impact-scored obligation register your engineers actually read.
ISO 13485 and MDSAP-ready QMS design, implementation and internal audit — procedure sets, CAPA discipline and management review that hold up under questioning.
510(k), CE marking and CDSCO dossiers built from your engineering inputs — clinical evidence, usability, risk and verification assembled into a coherent submission.
IEC 62304 and IEC 81001-5-1 for connected devices and AI-enabled products — safety classification, software documentation and AI risk obligations, handled properly.
Global vigilance that keeps running after launch — trend reporting, PSUR/PMS reports, recall readiness and field-safety corrective action workflows.
We run the mock inspection so the real one is uneventful — pre-audit gap analysis, document readiness scoring, and rehearsal of the answers your team will be asked for.
02 — Sample findings
In every assessment we rank clauses by exposure — what an inspector can fail you on, what can stop a shipment, and what merely annoys. Here is a representative sample of what surfaced and what we did about it.
Design control records existed for the product but not for the spreadsheet used to compute shelf-life, so the data was unvalidated. We built a risk-based validation protocol, executed it, and wired it into change control with a periodic re-validation trigger.
Requirements were documented but not uniquely identified, so traceability matrices could not be reconstructed under review. We introduced a requirement ID scheme, a bidirectional matrix and a review gate in the design review checklist.
No documented decision tree existed to determine when a complaint met the reportability threshold, so reports were inconsistently filed. We authored the decision tree, trained the team and put a mandatory triage field in the complaint form.
Two critical suppliers had been qualified verbally with no recorded criteria, and incoming inspection relied on a visual check of the supplier's CoA. We set objective acceptance criteria, added sampling plans and put supplier performance into the management review.
Particle monitoring records were kept but not trended, so excursions were discovered during audits rather than in time. We set alert and action limits, installed automated trending, and defined the excursion workflow with a defined product-impact assessment step.
CAPA records showed actions were taken but never verified for effectiveness, so repeat issues recurred under a new ticket number. We introduced effectiveness criteria at CAPA closure, a 90-day verification window and a recurrence linkage field.
03 — Method
No discovery theatre. Each stage ends with a signed artefact you can show a regulator, and a checkpoint you must clear to proceed.
We map your product family, intended claims, markets and current documentation, then score every applicable clause for exposure.
Week 1 — 2Line-by-line comparison of current state against the clause, with the evidence gap stated plainly and remediation costed in effort, not rupees.
Week 2 — 5Procedure sets, forms, templates and records are drafted with your team, then run on live cases so the process is proven before it is documented as final.
Week 5 — 16Mock inspection against the same checklist the notified body uses, followed by handover with training, internal auditor qualification and a maintenance calendar.
Week 16 — 2004 — Evidence
Aggregated across recent engagements, client-anonymised. Cycle time measured from kick-off to the first successful submission or certification decision.
| Engagement | Clause focus | Severity | Findings | Cycle before | Cycle after |
|---|---|---|---|---|---|
| ENG-2417Class II device — EU MDR, CE marking | Annex I / GSPR | Critical | 9 closed | 11 mo | 6 mo |
| ENG-2503IVD analyser — CDSCO + EU IVDR | 6.3 / 7.1 | Critical | 12 closed | 14 mo | 8 mo |
| ENG-2511Saas-connected pump — FDA 510(k) | IEC 62304 / 820.30 | Major | 7 closed | 9 mo | 5 mo |
| ENG-2526Surgical consumables — ISO 13485 | 7.5.8 / 8.2.2 | Major | 5 closed | 6 mo | 3 mo |
| ENG-2534AI triage software — EU AI Act | Risk class / 81001-5-1 | Observation | 4 closed | — | 4 mo |
| ENG-2540Post-market programme — EU PMS | 83 / 86 | Minor | 3 closed | 7 mo | 4 mo |
| ENG-2548Combination device — FDA + EU parallel | Design history | Critical | 14 closed | 16 mo | 9 mo |
FIGURES ARE MEDIAN VALUES ACROSS ENGAGEMENTS CLOSED BETWEEN JANUARY AND SEPTEMBER 2026 · CYCLE = KICK-OFF TO FIRST REGULATORY DECISION
05 — Engagement
Start with the smallest thing that answers your actual question. Most engagements begin as a gap assessment and grow from there.
A fixed-scope, fixed-fee review against the clauses that carry real exposure, delivered as a ranked findings register with a costed remediation plan.
Full build of the QMS, records and submission file, run alongside your team with training, mock inspection and handover into your internal process.
A standing bench covering monitoring, vigilance, change control and audit preparation, so obligations are met continuously rather than in a panic before deadlines.
06 — Contact
Send the regulation you are facing, the market you need, and the date that matters. We reply with an honest read on feasibility — including when the answer is that you do not need us.