Quality & Compliance

Quality & Compliance for Clinical, Diagnostics,

and Research Kitting & Logistics

Aligned to regulations, built for program success

Our ISO 13485-certified quality system and HITRUST-certified data environment are designed to keep your program running safely and smoothly. They prevent issues before they escalate, protect specimens and data, and ensure kits perform as expected.

Talk to a Kitting & Logistics Expert

How We Manage Quality & Compliance

Operational systems that protect performance, traceability, and trust

We manage quality and compliance through structured processes, trained teams, and certified systems that align with the standards your program requires. Every step—kit build, labeling, tracking, and documentation—is verified to keep operations consistent, data traceable, and shipments moving without risk or rework.

ISO 13485-Certified

Our quality management system is certified to ISO 13485, the international standard governing the manufacture, re-packaging, and distribution of medical devices. Every kit is built consistently, traceable by design, and documented to meet the demands of healthcare and clinical research.

Documented Quality Control

Traceability at the Kit Level

Inspection-Ready Documentation

HITRUST i1 Certified

Our information security environment is certified to HITRUST i1, the framework for protecting sensitive healthcare data. From data intake to fulfillment, our controlled processes ensure participant privacy at every step.

Secure Print & Data Workflows

Access-Controlled Infrastructure

Privacy-Safe Participant Materials

FDA-Registered Repackager

As an FDA-registered repackager and relabeler, we follow documented procedures for compliant handling, labeling, and controlled kit assembly and fulfillment.

FDA-Compliant Repackaging & Relabeling

Controlled Kit Assembly & Fulfillment Workflows

Regulated Component Handling

Built-In Quality Control

Quality is embedded into every step of our process. From component verification to final quality release, each kit goes through documented inspections to ensure accuracy, consistency, and compliance.

Multi-Step QC Checkpoints

Component & Label Verification

Final Quality Release

Deliver Better Health With Operational Support That Scales

From pilots to national rollouts, we help you build, ship, and manage compliant kits that move your mission forward.

Let’s Talk Quality & Compliance

Why WellPact

Why Choose WellPact for Quality & Compliance

Our systems are aligned to the demands of clinical, diagnostic, and research programs. Built to meet FDA, ISO, and HIPAA standards.

Quality checks are built into every step, with documented inspections that keep kits accurate, complete, and consistent across every lot.

From serialized components to kit-level documentation, our workflows support full visibility across production, labeling, and returns.

You stay focused on patient care, trial execution, or lab throughput. We handle the compliance and quality behind every kit so your program stays protected and moving forward.