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. This system exceeds federal and industry standards for safety, quality, data protection and environmental responsibility.
Stated below is a comprehensive summary of how the system meets the applicable regulatory and quality benchmarks.
Regulatory Standards
There are different regulatory standards that must mbe metby everyone.
FDA 510(k) Cleared Sharps Containers.
This clearance confirms containers must meet established criteria for puncture resistance, leak protection, secure closure, and safe handling in alignment with 21 CFR 880.5570. All Pureway sharps containers are FDA-cleared medical devices under the 510(k) premarket notification process.ISO 23907 Adherence to Sharps Injury Protection.
These standards include overfill protection, robust lid security, and tamper resistance to support OSHA Bloodborne Pathogens Compliance (29 CFR 1910.1030). Sharps containers meet ISO 23907 standards, ensuring best-in-class protection from needlestick injuries.
ISO 13485 Adherence to Quality System.
These standards include risk management, process validation, and design control throughout the product lifecycle. PureWay's manufacturing partners operate under an ISO 13485 Quality Management System, which ensures traceable, documented, and consistently high-quality production of medical services.
SOC 2 Type II Certified for Data Security
This SOC 2 Type II safeguards customer information and ensures secure chain-of-custody documentation. PureWay maintains this SOC 2 Type II certification, verifying that all platforms and data handling procedures meet rigorous standards for security, availability, confidentiality, and privacy.
USPS and 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). Under this compliance, packaging must include the following:
Pre-labeled return boxes
Manifest Tracking
Destruction documents to support complete cradle-to-grave information.
Commitment to Continuous Improvement
PureWay's commitment to continuous improvement extends beyond compliance. Investing in the following factors, such as:
Training
System Updates
Customer Support
Regulatory Monitoring
With these, PureWay stays ahead of changes and ensures protection. Every product and process is being reviewed with safety, compliance, and end-user experience in mind.
Audits, Reviews, and Regulatory Oversight
To ensure the continuity of compliance, PureWay engages in the following annual and recurring regulatory activities:
FDA Device Listing and Establishment Registration
This is being renewed annually as required under 21 CFR Part 807.ISO 13485 Surveillance and Recertification Audits
This is being conducted annually by third-party notified bodies to validate QMS adherence.SOC 2 Type II Audit
An independent CPA firm audits this annually to verify sustained controls around data security, privacy, and system integrity.Internal Quality Audit
This is being performed quarterly to assess risk controls, manufacturing records, CAPA processes, and document control.DOT and USPS Compliance Reviews
This is a regular internal review of packaging, labelling, and manifesting to ensure strict adherence to 49 CFR and USPS Publication 52 for medical waste (UN3291).Customer Feedback and Incident Tracking
This involves continuous monitoring and trend analysis to identify areas for product and process improvement.
PureWay Compliance made simple.
Access documentation, training tools, and state-specific regulations below.