Quality, Built into Every Step
Healthcare diagnostics is too consequential for compliance to be a paperwork exercise. We treat certifications as systems we live inside — audited continuously, retrained constantly, and improved every cycle.
Compliance isn't a project. It's how the company runs.
The badges below aren't there for the website. They're the operating standards that shape how we hire, how we train, how we build, and how we ship — every day. Each one raises a different bar, and meeting all of them together is what lets us act as a single accountable partner across kitting, courier, phlebotomy, and technology.
Maintaining six certifications doesn't happen by accident. It takes a quality function with documented procedures, recurring internal audits, and a culture where every team member knows their role in keeping the system honest. The discipline of running an FDA-registered, ISO-certified, HIPAA-compliant operation is what separates a vendor who ticks a box at sign-off from a partner who's still operating at the same standard a year, three years, ten years into the relationship.
Six standards, one accountable partner
Each certification raises a specific bar — and each one makes us better at a specific part of the job.
ISO 9001 Certified
Quality Management Systems
Documented quality policies, internal audit cycles, and a structured continuous-improvement process — every team works from the same playbook, and that playbook gets sharper every cycle.
ISO 13485:2016 Certified
Medical Device Quality Management
Brings the rigor of medical-device manufacturing into our kitting operations — risk management, design controls, and lot-level traceability that match what device makers themselves are held to.
FDA Registered Facility
U.S. Food and Drug Administration
We operate under FDA oversight. Facility, processes, and records meet federal standards for medical-device handling — and we're inspection-ready year-round, not just when an audit is announced.
HIPAA Compliant
Patient Privacy & Data Security
Every system that touches protected health information — kitting work orders, specimen tracking, integrations — is built under HIPAA's privacy and security rules with role-based access, audit logs, and encrypted transmission.
IATA Certified
Dangerous Goods & Air Transport
IATA-trained packing, labeling, and documentation for biological substances and dry-ice shipments — so specimens fly with the right paperwork and the right protection, every time.
TSA Approved
Certified Cargo Screening
Pre-screened cargo handling lets our shipments move faster through air freight — no last-minute security holds, no broken chain of custody on time-sensitive specimen logistics.
Certified once. Audited continuously.
Most providers treat compliance like a checkbox — pass the audit, frame the certificate, move on. We treat it as a system that has to keep working between audits.
These four pillars run year-round so quality keeps compounding instead of decaying.
Continuous internal audits
Quality audits run on a recurring cadence — not just before external assessments. Findings feed straight into corrective actions with named owners and deadlines.
Ongoing training & recertification
Staff training is tracked, scheduled, and recurring — DG/IATA, HIPAA, GMP, and role-specific procedures are recertified on a defined cycle, never left to drift.
Documented procedures, version-controlled
Every SOP lives in a controlled document system with revision history, approval workflows, and read receipts so the whole team works from the latest source of truth.
Closed-loop feedback
Client and partner findings feed our CAPA (Corrective and Preventive Action) process — the same system we use for internal non-conformance — so improvements compound across the network.