Class I and II device manufacturers operate under FDA and ISO 13485 requirements that demand traceable, auditable evidence. But when DHR data is scattered across systems, supplier documents are in email, and audit prep is a scramble, compliance becomes a burden that pulls your team away from innovation. The device makers who scale are the ones whose systems generate compliance evidence automatically.
Launchpad captures the failure modes that create operating drag and places the technology response on the Roadmap: disconnected systems, weak records, manual handoffs, compliance exposure, and AI blocked by unreliable data. Metrotechs scopes and delivers the engineering work.
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.
Pre-audit documentation is assembled manually — design records, risk assessments, validation studies, training records. The quality team spends weeks pulling documents from disparate systems. Auditors always find gaps. You remediate the same issues every cycle.
The goal is not software for its own sake. The goal is an operating stack where the right records, workflows, controls, and AI use cases are governed by systems your team owns.
When production parameters, lot numbers, and quality data are captured in one system, DHR completeness is automatic. Every production decision is traceable. Traceability investigations take hours, not weeks.
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 records, risk assessments, validation documentation, and training records live in the system, audit prep is a report run — not a weeks-long search through email. Auditors see control, not chaos.
When your system generates the compliance evidence automatically, your quality team focuses on preventing problems instead of documenting them 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.
Launchpad records this pressure, the evidence, owners, and risks on the Roadmap. Metrotechs scopes the AI, data, cloud, ERP, integration, workflow, reporting, and governance work required to address it.
Launchpad records this pressure, the evidence, owners, and risks on the Roadmap. Metrotechs scopes the AI, data, cloud, ERP, integration, workflow, reporting, and governance work required to address it.
Launchpad records this pressure, the evidence, owners, and risks on the Roadmap. Metrotechs scopes the AI, data, cloud, ERP, integration, workflow, reporting, and governance work required to address it.
Launchpad records this pressure, the evidence, owners, and risks on the Roadmap. Metrotechs scopes the AI, data, cloud, ERP, integration, workflow, reporting, and governance work required to address it.
Metrotechs and the client use Launchpad to structure the current state and record priorities, dependencies, owners, risks, and stage gates. Metrotechs then architects and delivers the AI, data, cloud, ERP, integration, workflow, reporting, and governance work the managed Roadmap identifies.
Metrotechs reviews how you currently capture and maintain DHR, supplier qualification documents, design records, and validation documentation. Metrotechs quantifies the cost of dispersed systems and manual traceability.
Metrotechs maps 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.
Metrotechs configures 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 readiness areas narrow the first assessment into concrete AI, data, cloud, ERP-connected, integration, workflow, reporting, and governance decisions.
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.
Launchpad captures the operating constraint, practical AI opportunities, data dependencies, cloud control, ERP records, integration handoffs, workflow constraints, reporting gaps, owners, and risks. Metrotechs uses the Roadmap to scope delivery.
