Z2 gives medical device manufacturers the lifecycle intelligence, compliance data, and PCN workflows to manage component risk without triggering unnecessary design change submissions, while keeping FDA and EU MDR audit trails current.
The Challenge
A single discontinuation triggers 12–18 months of design control, re-qualification, and regulatory submission. Teams that get late notice face an impossible timeline.
PCNs arrive in email, require regulatory impact assessment, and must be documented for FDA and EU MDR auditors. Most organizations lack a systematic process for handling the volume.
RoHS exemptions narrowing, PFAS restrictions advancing, EU MDR traceability requirements, UFLPA. Each new obligation requires component-level visibility that ERP systems don't carry.
Disruption Monitoring Monitor CMO and CDMO supplier sites for continuity planning. Real-time alerts on shortages, logistics disruptions, and geopolitical events mapped directly to your device BOMs and production schedules.
RoHS, REACH & PFAS Automated BOM screening for RoHS exemptions, REACH SVHCs, PFAS substance mapping, Conflict Minerals, and Prop 65. Generate compliance declarations for regulatory submissions without chasing suppliers.
Obsolescence & Lifecycle DHF-ready lifecycle data for every component in your device BOM. Prevent costly design changes with 12–36 month forward visibility into component discontinuations before they force a re-qualification.
Supplier Quality Risk ISO 13485 certification status, FDA establishment registration, and bankruptcy-risk scoring for every supplier in your approved vendor list. Stay ahead of quality system lapses before they trigger a CAPA.
Built for enterprises that need unified risk coverage across parts, suppliers, compliance, and minerals, with a single integration point and shared workflow.
PCN & Design Change Management
When a component supplier issues a discontinuation notice (with or without a formal PCN), medical device teams face a decision that consumes months of engineering and regulatory bandwidth. Z2's PCN Manager intercepts changes at the source, routes them to the right team, and builds the audit trail that 21 CFR Part 820 requires.
Capabilities
Lifecycle forecasting flags discontinuation risk years ahead, giving device teams time to qualify a replacement without a design change submission.
Auditable PCN processing routes every change notification by device and program while building the impact-assessment trail 21 CFR Part 820 design control requires.
Tracks RoHS exemption sunset dates across the portfolio so you know which devices depend on narrowing exemptions before they expire.
Component-level SVHC screening and PFAS mapping identify substance exposure across every cleared device and generate the documentation regulators and customers require.
Maps your supply chain from Tier 1 through sub-tier manufacturers and raw material origins for MDR Article 10 and UFLPA obligations, without manual supplier questionnaires.
ISO 13485 status, financial health scoring, and continuity monitoring surface contract manufacturer and CDMO quality risk before it triggers a CAPA or production stoppage.
DMSMS Intelligence
Z2's Part Risk Manager monitors every commercial component in your device BOM, surfacing lifecycle alerts the moment a part moves to not recommended for new design or approaches end-of-life. Component engineers get qualified alternates. Regulatory teams get the change impact assessment. Procurement gets the last-time-buy window.
Part Risk Manager
Compliance & Regulatory
Medical device compliance obligations keep expanding. Z2 Compliance Manager continuously screens your BOM against RoHS exemptions, REACH SVHCs, PFAS, and conflict minerals requirements, and generates the documentation your regulatory team and auditors require without last-minute scrambles.
Compliance Manager
Use Cases
Thirty percent of component discontinuations receive no formal PCN. Z2's proprietary lifecycle forecasting surfaces risk before manufacturer announcements, giving component engineers time to qualify alternates under controlled conditions.
PCN disposition records, FDA audit trails, and EU MDR documentation are built automatically as changes flow through the platform, so regulatory affairs teams have the evidence package ready before the inspection date.
Substance-level PFAS tracking through sub-tier suppliers gives compliance engineers a complete picture of chemical exposure across the device portfolio, and generates the disclosure documentation that customers and regulators increasingly require.
Supply Chain Watch monitors contract manufacturer and CDMO sites continuously. When a site event occurs, alerts map directly to the devices and production schedules at risk, so supply chain teams can act on specifics, not headlines.
Regulatory Traceability
EU MDR Article 10 requires manufacturers to maintain complete supply chain traceability for every device on the market. EUDAMED mandatory use begins May 2026. Z2's Sub-Tier Intelligence maps your supply chain to the component and raw material level, satisfying traceability obligations without manual supplier questionnaires.
Map your supply chain from Tier 1 through sub-tier manufacturers and raw material origins to satisfy EU MDR documentation requirements for every CE-marked device.
Continuous matching of your Tier 1 and sub-tier suppliers against UFLPA entity lists with automated alerts when new designations affect your supply chain.
Build the device and component data structure that EUDAMED mandatory reporting requires, before the deadline creates a compliance gap across your device portfolio.
Z2 not only saves me time but also that of the regulatory compliance, procurement, and design teams. Each department saves so much time using Z2's platform.
Common Questions
Z2 Part Risk Manager forecasts component end-of-life 12 to 36 months ahead, giving teams time to plan alternate qualification before a discontinuation notice arrives. Because a single component change can trigger a 12-to-18-month design-control and 510(k) or PMA supplement process, early lead time is the difference between a planned change and a stoppage.
Yes. Z2 Sub-Tier Intelligence maps the full component supply chain for EU MDR Article 10 traceability, and Supplier Insights provides ISO 13485 certification and FDA registration status. PCN Manager creates the auditable change records that 21 CFR Part 820 and notified-body reviews require.
Z2 Compliance Manager tracks RoHS, REACH SVHC, PFAS, and Prop 65 status per component and monitors exemption expiry dates across the full portfolio. Because medical devices rely on time-limited exemptions for substances like lead in certain solders, Z2 flags approaching sunsets before a device must requalify under IEC 60601 or exit the EU market.
Yes. Z2 enables direct retrieval of Full Material Declaration documents from suppliers and maintains component-level RoHS and REACH records across 1B+ parts. This replaces the manual portal-by-portal document pull compliance engineers perform before audits, where producing outdated records creates findings.
Yes. Z2 is SOC 2 Type I and Type II compliant and GDPR compliant, encrypts data at rest with AES-256 and in transit with TLS 1.2 and 1.3, and offers SSO with SAML 2 for enterprise customers. Customer BOM data is logically segregated by customer and removed when an organization is no longer a customer.
