NRE & DESIGN SPECIALIST
NRE & Design Specialist
- Product requirements, LoC architecture, and design
- CAD, BOM, prototypes, and DFM
- NRE outputs and technology-transfer package
MANUFACTURING PRIME / QUALITY OPERATIONS
TROVA HEALTH
One accountable partner for lab-on-a-chip manufacturing and quality evidence
We connect NPI, production operations, URS, usability validation, IQ/OQ/PQ, and quality monitoring for RUO and engineering pilot programs.
RUO · Pilot · NPI Validation · Quality OperationsCommercial IVD manufacturing begins after facility, license, and GMP scope are confirmed
OPERATING MODEL
Separate the roles.
Make customer accountability clear.
Design authority and manufacturing accountability are separated by contract and deliverables. Through Trova Health, customers see quality, delivery, cost, and release status against one operating standard.
MANUFACTURING PRIME & QUALITY OPS
- Quotation, contracting, purchasing, and supplier control
- NPI, process transfer, production, and lot records
- Inspection, release, CAPA, complaints, and recall operations
Commercial IVD manufacturing is contracted after facility-use and quality agreements, licenses, and GMP scope are confirmed. Our current scope is RUO and engineering pilot work, NPI, validation, and quality operations.
SERVICES
From design transfer
to maintained validation
We connect requirements, processes, raw data, review records, and change history so the evidence supports the next decision rather than a one-time test.
01
NPI & Technology Transfer
We transfer design outputs into production-ready processes and records, then assess readiness for pilot execution.
- Technology transfer checklist
- Process flow and draft work instructions
02
RUO & Engineering Pilot Lots
We produce engineering and research-use lots while linking process conditions, inspection results, and lot history.
- Lot execution plan
- Manufacturing and process records
03
URS & V&V
We connect user requirements, risks, test items, acceptance criteria, traceability, and results reporting.
- URS and requirements list
- Risk-based test plan
04
Usability Validation
We define intended users, environments, critical tasks, and use errors, then document observable evidence.
- Use specification
- Critical task and risk matrix
05
IQ, OQ & PQ Qualification
We structure installation, operating-range, and performance evidence with deviation and retest criteria.
- IQ protocol and results
- OQ protocol and results
06
Quality Monitoring
We review change impact, performance drift, deviations, CAPA, and quality indicators on a recurring cadence.
- Quality indicator definitions
- Change and CAPA register
AI AGENT
See the documents
and sequence
before kickoff
The initial version uses an expert-designed rules engine with no per-use model fee. Organize scope before consultation, then have the final decision reviewed by a quality lead.
No personal data required No AI API fee Expert review available
Open the dedicated page 01
Select a subject and stage to organize the documents, evidence, and execution sequence you need.
DOCUMENT PACK
Five editable documents
to start validation
Editable DOCX drafts with document control, requirement-test traceability, result records, and review and approval fields.
Equipment User Requirements Template
Requirements, rationale, risk, verification method, acceptance criteria, and traceability
Usability Validation Template
Users, environments, critical tasks, scenarios, observations, use errors, and conclusions
Installation Qualification Template
Installation environment, components, documentation, utilities, calibration, and safety
Operational Qualification Template
Operating ranges, alarms, interlocks, worst-case conditions, and test results
Performance Qualification Template
Actual conditions, repeats, lots, operators, performance metrics, and disposition
COMPANY
Quality, science, production, and business development
in one accountable operating system.
Leadership & Team
We distinguish executive accountability, operating expertise, and the role of external technology partners.
Co-CEO
Yujin Jeon
Co-CEO · Quality & Operations
A quality leader with 20 years of experience in IVD manufacturing quality and on-site operations.
- QMS and validation
- NPI and lot disposition
- Deviation and CAPA
Co-CEO
Jiyoung Moon
Co-CEO · R&D & Programs
A Ph.D. in science education leading national R&D, research design, and science and technology programs.
- National R&D
- Research design and dissemination
- Science and technology education
Junkyu Choi
External PartnerNRE · Design Partner
An external partner supporting bio-MEMS and lab-on-a-chip design and commercialization, with graduate research training at Seoul National University.
- Bio-MEMS and LoC
- R&D review and collaboration
- Technology commercialization
Hae-Woong Lee
Executive Director · Chief Business Officer
A 20-year medical and biotech business leader advancing liquid-biopsy and AI medical-device commercialization.
- Global business development
- Clinical and regulatory strategy
- Technology marketing
Byungjae Moon
Manufacturing Operations Lead
Connects production planning, materials, and inventory to stable execution and reliable shop-floor records.
- Production and material planning
- ERP production and logistics
- Shop-floor documentation
Seungcheol Yang
External PartnerCEO, U-Studio · Strategic AI Partner
A former Microsoft MVP supporting AI automation and evidence-based operating systems.
- AI automation and RAG
- Agentic workflows
- Workforce enablement
History
Trova Health Co., Ltd. commenced operations
Co-CEO structure with Yujin Jeon and Jiyoung Moon agreed
Expansion strategy centered on manufacturing accountability and quality operations adopted
Wonju sales and validation office activated; Chuncheon production model under discussion
URS, usability, IQ/OQ/PQ document pack and Scope Agent released
Trova Health Co., Ltd.Manufacturing & Quality Operations
- Business registration
- 665-81-02691
- Established
- October 2022
- Registered office
- Suite 610, 200 Gieopdosi-ro, Jijeong-myeon, Wonju-si, Gangwon State, Republic of Korea
- Operations
- Wonju sales and validation / Chuncheon production site planned
Chuncheon production starts after the facility contract and authorization scope are confirmed.
START A PROJECT
Define the manufacturing and validation scope
you need now.
You do not need a completed URS or production cost sheet. Tell us the subject, current stage, and most concerning failure condition, and we will organize the right NPI, validation, and quality operations scope.
We respond within two business days after reviewing your request.