Medical-device manufacturers need design, supplier, production, quality, training, complaint, and traceability evidence governed across the systems and teams responsible for the product lifecycle.
These are the points where useful industry systems often stop supporting the work around them. We trace the record, owner, decision, and downstream consequence before recommending a technology response.
DHR completeness is discovered during audit or quality investigation — not maintained in real time. Records are scattered across production logs, email, and shared drives. Traceability is reconstructed after the fact. FDA finds gaps. You scramble to close them.
Vendor assessments, supplier audits, and compliance certificates are stored in email archives and shared drives. When you need to prove a supplier was qualified or audited, finding the evidence takes days. Regulatory queries are nightmares.
When design records, risk assessments, validation studies, supplier evidence, and training records are scattered, the quality team must reconstruct the review package and may repeat the same remediation work across cycles.
The goal is not more software. It is clearer work, dependable records, accountable exceptions, and technology the business can operate and improve.
Connecting approved production, lot, quality, and release records gives accountable teams a clearer way to review completeness and trace the evidence behind a device history record.
When supplier assessments, audit reports, and compliance documents are centralized and version-controlled, you can answer "prove this supplier was qualified" in minutes. Regulatory inquiries become routine.
When design, risk, validation, supplier, and training evidence is governed with ownership and revision history, review preparation begins from known records instead of an email search.
When normal workflows capture the required evidence and exceptions, the quality team can spend more time reviewing risk and improving the process instead of reconstructing activity after the fact.
Metrotechs is a fit when the real problem is not one application. It is the handoff between records, approvals, production, fulfillment, finance, reporting, and customer commitments.
This operating context can shape the records, controls, integrations, and change sequence the business needs.
This operating context can shape the records, controls, integrations, and change sequence the business needs.
This operating context can shape the records, controls, integrations, and change sequence the business needs.
This operating context can shape the records, controls, integrations, and change sequence the business needs.
We begin with operating evidence, define the result and constraints, then sequence the smallest sound response. Launchpad is available when the work needs a governed Roadmap across multiple priorities.
We review how you currently capture and maintain DHR, supplier qualification documents, design records, and validation documentation. We quantify the cost of dispersed systems and manual traceability.
We map how ERP will capture production parameters for automatic DHR generation, maintain centralized supplier records, and store design and validation documentation so everything is version-controlled and auditable.
We configure the system, migrate your documentation, and validate that the system generates compliant records. Your quality team is trained to maintain regulatory control inside the system.
These areas help determine whether the right response is process clarification, data cleanup, integration, reporting, workflow improvement, a platform change, or a broader transformation Roadmap.
Reviews how DHR data is currently captured and stored. Identifies gaps and quantifies the cost of manual traceability investigations.
Assesses current supplier management practices against FDA/ISO 13485 requirements. Identifies documentation gaps and shows the cost of regulatory exposure.
Measures the time and effort required for current audit preparation. Identifies documentation that exists but is hard to find. Quantifies the opportunity for automated compliance evidence.
These services address the ERP records, operational data, automation opportunities, customer workflows, and system dependencies behind the operating pressures above.
Connect finance, orders, inventory, purchasing, fulfillment, and reporting around an owned system of record.
Explore serviceService pathBuild governed pipelines, shared definitions, and operational reporting across ERP and connected applications.
Explore serviceService pathApply AI to documents, exceptions, decisions, and workflows only after access, ownership, and review controls are clear.
Explore serviceBring us the part of the operation that is slowing down, producing unreliable information, or making a customer commitment harder to keep. We will follow the issue across the business before defining the work.
