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INOVASENSE
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2026 REGULATORY READY

Hardware Product Management

V-model product lifecycle from discovery to end-of-life — managed with gate reviews, BOM risk analysis, and full EU regulatory traceability. We navigate CRA, AI Act, CBAM, and Ecodesign so you ship on time.

€40K–500K+
NRE Budget Range
4–8 wk
First Prototype
>95%
First-Pass Yield
100%
EU Supply Chain

Why Inovasense

Hardware product management in 2026 means navigating a regulatory landscape that didn't exist three years ago. The EU Cyber Resilience Act mandates vulnerability handling and SBOMs. The AI Act classifies your edge inference module. CBAM adds carbon cost to your BOM. We manage all of this — from the first requirements workshop to volume production — so your engineering team focuses on the product, not the paperwork.

Product Lifecycle Phases

01

Discovery & Requirements Engineering

Structured requirements capture with full traceability (DOORS/Jira). Technology trade studies with quantified criteria — BOM cost, power budget, certification scope, supply chain risk.

→ Requirements Specification (SRS/HRS) → Feasibility Report with BOM risk matrix → Project Plan with NRE budget & milestone gates
02

Architecture & Design

V-model development with CR→DR→PR gate reviews. Schematic and PCB design in Altium Designer with dual-source BOM strategy. Design FMEA and worst-case analysis before first spin.

→ System Architecture Document → Schematic & PCB layout (Altium) → Design FMEA & thermal analysis
03

Prototype & Validation

First prototype in 4–8 weeks from requirements sign-off. Pre-compliance EMC screening to catch issues before €3K–8K lab visits. DV/PV testing against qualification matrix.

→ Functional prototype with test report → Pre-compliance EMC/EMI results → DV/PV test matrix & pass/fail
04

Certification & Compliance

Full CE marking: EMC (EN 55032/55035), Safety (EN 62368-1), RED (EN 300 328/220). EU Cyber Resilience Act (2024/2847) readiness. AI Act classification for edge computing products.

→ Technical File & Declaration of Conformity → CRA vulnerability management plan → UKCA / FCC / IC parallel submissions
05

NPI & Volume Production

New Product Introduction with PPAP, first article inspection, and EOL test fixture qualification. DFM/DFA reviews with EMS partner. IPC Class 2/3 workmanship. Production yield tracking (target >95% first-pass).

→ Production-ready Gerber & assembly files → Test fixture & programming jig → Serial number traceability system
06

Sustaining & End-of-Life

Post-launch firmware updates (OTA), field failure analysis, and component obsolescence management. EU Right-to-Repair compliance. Planned EOL with last-time-buy strategy and customer migration path.

→ OTA update infrastructure → Component obsolescence watchlist → EOL notification & migration plan

2026 Regulatory Landscape

The EU regulatory environment for electronics is the most complex it has ever been. We track and integrate compliance for all of these into your product lifecycle.

EU Cyber Resilience Act

Mandatory 2027

EU 2024/2847

Vulnerability handling, SBOM, 5-year security updates for all connected products.

EU AI Act

Phased 2025–2027

EU 2024/1689

Risk classification for products with embedded AI/ML inference at the edge.

CBAM

Active 2026

EU 2023/956

Carbon Border Adjustment Mechanism — carbon cost reporting for imported components.

EU Chips Act

Active

EU 2023/1781

Supply chain resilience, semiconductor sovereignty, and crisis monitoring obligations.

Ecodesign (ESPR)

Phased 2025–2030

EU 2024/1781

Digital Product Passport, repairability scoring, and recycled content mandates.

RED Delegated Act

Mandatory Aug 2025

EU 2022/30

Cybersecurity baseline for all radio equipment — authentication, secure boot, update mechanisms.

Our Methodology

V-Model

Development Framework

Verification and validation at every level — from component to system. Each design phase has a corresponding test phase with pass/fail criteria defined upfront.

Gate

Milestone Reviews

CR→DR→PR→DV→PV reviews with mandatory sign-off criteria. No phase proceeds without documented gate approval. Budget and timeline re-baselined at each gate.

FMEA

Risk Quantification

Design FMEA, Process FMEA, and BOM risk matrix maintained as living documents. Risk priority numbers (RPN) drive design decisions and supply chain strategy.

Technical Domains We Manage

Next Step

Start with a Requirements Workshop

NDA-first engagement. 2–3 day structured workshop to define requirements, identify regulatory scope (CRA, AI Act, RED), and produce a budgeted project plan — before any engineering commitment.