📜 Compliance Summary
PureWay’s sharps disposal by mail system is a fully compliant, turnkey solution engineered to help healthcare providers and organizations safely and legally manage sharps waste.
The system exceeds federal and industry standards for safety, quality, data protection, and environmental responsibility.
Below is a comprehensive summary of how the system meets all applicable regulatory and quality benchmarks.
✅ FDA 510(k) Cleared Sharps Containers
PureWay’s sharps containers are FDA-cleared medical devices under the 510(k) premarket notification process.
This clearance confirms containers meet established criteria for puncture resistance, leak protection, secure closure, and safe handling, in alignment with 21 CFR 880.5570.
✅ ISO 23907 adherence – Sharps Injury Protection
All sharps containers meet ISO 23907 standards, ensuring best-in-class protection from needlestick injuries.
Design features include overfill protection, robust lid security, and tamper resistance to support OSHA Bloodborne Pathogens compliance (29 CFR 1910.1030).
✅ ISO 13485 adherence Quality System
PureWay’s manufacturing partners operate under an ISO 13485 Quality Management System, which ensures traceable, documented, and consistently high-quality production of medical devices.
This includes risk management, process validation, and design control throughout the product lifecycle.
🔁 Ongoing Audits, Reviews, and Regulatory Oversight
To ensure continual compliance, PureWay engages in the following annual and recurring regulatory activities:
FDA Device Listing & Establishment Registration – Renewed annually as required under 21 CFR Part 807.
ISO 13485 Surveillance and Recertification Audits – Conducted annually by third-party notified bodies to validate QMS adherence.
Internal Quality Audits – Performed quarterly to assess risk controls, manufacturing records, CAPA processes, and document control.
DOT & USPS Compliance Reviews – Regular internal reviews of packaging, labeling, and manifesting to ensure strict adherence to 49 CFR and USPS Publication 52 for medical waste (UN3291).
SOC 2 Type II Audit – Annually audited by an independent CPA firm to verify sustained controls around data security, privacy, and system integrity.
Customer Feedback & Incident Tracking – Continuous monitoring and trend analysis to identify areas for product and process improvement.
🔒 SOC 2 Type II Certified – Data Security
PureWay maintains a SOC 2 Type II certification, verifying that all platforms and data handling procedures meet rigorous standards for security, availability, confidentiality, and privacy.
This safeguards customer information and ensures secure chain-of-custody documentation.
📦 USPS & DOT Shipping Compliance
All mail-back kits are fully compliant with DOT Hazmat regulations (49 CFR Parts 171–180) and USPS standards for regulated medical waste (UN3291).
Packaging includes pre-labeled return boxes, manifest tracking, and destruction documentation to support full cradle-to-grave compliance.
🛡️ Commitment to Continuous Improvement
PureWay’s commitment extends beyond compliance — we invest in training, system updates, customer support, and regulatory monitoring to stay ahead of changes and ensure clients are always protected.
Every product and process is reviewed with safety, compliance, and end-user experience in mind.
PureWay helps you stay compliant, confident, and protected. For documentation, training resources, or state-specific regulations, visit: