ISO 13485 Certified Company for Medical Kit Assembly and Healthcare Logistics
Supera Fulfillment is an ISO 13485 certified company providing medical kit assembly, specimen collection kit fulfillment, aliquoting, and healthcare logistics services to diagnostic laboratories, clinical research organizations, and at-home testing brands across the United States. Our ISO 13485 certification, combined with FDA registration and ISO 7 cleanroom operation, places our Houston facility within the quality management framework that regulated medical device and diagnostic supply chains require from their fulfillment partners.
Certifications you can verify
Both certifications below cover our Houston facility at 3240 Fuqua St, Suite 3246. Certificate numbers, scope and dates are published here so you can confirm them directly with the issuing body.
- Registrar
- NSF International Strategic Registrations (NSF-ISR), Ann Arbor, MI
- Certificate number
- C0632412-MD2
- Certified scope
- Kitting, labeling, re-packaging, solution filling into vials, packaging, and capping and de-capping of vials and tubes intended for healthcare use.
- Issued
- April 25, 2025
- Valid through
- October 28, 2027
- Certifying firm
- ENV Services, Inc., Hatfield, PA
- Report control ID
- 228-370165-68903
- Result
- ISO Class 7 at 0.5 microns, Pass. Tested to ISO 14644 under an ISO 17025 accredited program.
- HEPA filter integrity
- Leakage at or below 0.01 percent, Pass
- Airflow and pressure
- 28 air changes per hour, positive pressure to ambient
- Last certified
- February 6, 2026
Texas Device Manufacturer License
- Issuing authority
- Texas Department of State Health Services, Regulatory Licensing Unit
- Authorized activity
- Device Manufacturer
- Statutory basis
- Texas Health and Safety Code Chapter 431, the Texas Food, Drug, Device and Cosmetic Act, and Title 25 of the Texas Administrative Code
- Licensed address
- 3240 Fuqua St, Unit 3246, Houston, TX 77047. Site specific and non-transferable.
- Expires
- February 27, 2027
- Renewal cycle
- Renewed every two years
A Texas device manufacturer license authorizes manufacturing activity at the licensed address under state law. It is separate from the certifications above, and it is not an FDA clearance, approval or classification.
Supera Fulfillment is also an FDA-registered establishment. ISO 13485 certification describes our quality management system and the cleanroom classification describes our assembly environment. Neither is a clearance, approval or classification of any client device or test.
What ISO 13485 Certification Means for Your Supply Chain
ISO 13485 is the international quality management standard specifically developed for organizations involved in the design, manufacture, storage, distribution, and servicing of medical devices and in vitro diagnostic products. Unlike ISO 9001, a general quality standard applicable across industries, ISO 13485 is written specifically for the regulatory environment that medical device companies and diagnostic laboratories operate within.
Certification requires an organization to implement and maintain a documented quality management system covering risk management, design controls, supplier qualification, process validation, equipment calibration, environmental monitoring, traceability, nonconformance management, corrective and preventive action, and complaint handling. These are not administrative exercises. In a medical kit assembly and fulfillment context, they are the operational controls that determine whether a kit leaves your facility correctly assembled, correctly labeled, within specification, and traceable to every component lot it contains.
For laboratories and diagnostic companies selecting a fulfillment partner, ISO 13485 certification is the baseline qualification that separates a compliant supply chain extension from a general logistics vendor operating outside the regulatory framework your products require.
What Working With an ISO 13485 Certified Company Looks Like in Practice
Supplier Qualification and Component Traceability
Every component that enters our facility (collection tubes, swabs, transport media, specimen containers, packaging materials) is received against a purchase order, inspected against defined acceptance criteria, and logged with full lot traceability. Supplier qualification records are maintained for all approved vendors including BD, Greiner Bio-One, Sarstedt, Streck, COPAN, and Zymo Research. Client-specified manufacturers are added to our approved vendor program through a documented qualification process before components are accepted into production.
Process Validation and Equipment Qualification
Our aliquoting program using the Hamilton STAR automated liquid handling system operates under a validated process. Equipment qualification records (installation qualification, operational qualification, and performance qualification) are maintained and available for client audit. Calibration schedules for all measurement equipment are managed within our quality system, with calibration records traceable to national measurement standards.
Environmental Monitoring
Our ISO 7 cleanroom is continuously monitored for airborne particulate levels, temperature, and humidity. Environmental monitoring results are recorded and reviewed against defined alert and action limits. Excursions trigger documented investigations under our corrective action procedure. This monitoring record is available to clients as part of lot documentation for products assembled in the cleanroom.
Lot Documentation and Certificates of Analysis
Every kit or product lot produced at our facility generates a complete batch record including component lot numbers, assembly date, operator records, in-process inspection results, environmental monitoring data from the production period, and final verification sign-off. Certificates of analysis are issued with every lot and structured to support client quality systems, regulatory submissions, and customer audits.
Nonconformance and CAPA Management
Deviations, nonconforming materials, and customer complaints are managed through our documented nonconformance and corrective and preventive action procedures. Root cause investigations, corrective action implementation, and effectiveness verification are documented and available for review. Our CAPA system covers both internal quality events and supplier-related nonconformances.
FDA Registration and the Regulatory Framework
ISO 13485 certification operates alongside, not instead of, FDA registration. Supera Fulfillment holds FDA registration as a medical device establishment (Registration No. 3018077536), which is required for facilities involved in the manufacture, assembly, or distribution of medical devices and in vitro diagnostic products in the United States. Our quality system aligns with FDA Quality System Regulations under 21 CFR Part 820, supporting clients who distribute FDA-regulated products through our facility.
Together, ISO 13485 certification and FDA registration mean that when a laboratory or diagnostic company uses Supera Fulfillment as a fulfillment partner, our facility qualifies as a compliant extension of their regulated supply chain, not a gap in it.
Founded on Clinical Laboratory Quality Standards
Supera Fulfillment was co-founded by Sitara Waidyaratne, a clinical laboratory professional with 25 years of experience managing quality systems, regulatory compliance, and pre-analytical workflows on the laboratory side of the diagnostic supply chain, and Michael Brown, a scientist and laboratory supply veteran with more than 25 years in the industry. The quality standards built into our ISO 13485 certified operation reflect that background, they are designed by someone who spent 25 years on the receiving end of kit assembly and fulfillment decisions, and who understands exactly how a quality failure in the supply chain translates into a quality failure in the laboratory.
Across diagnostic, research, clinical trial, and at-home testing programs, our quality system has been audited, validated, and stress-tested across the full range of regulated program types.
Related reading: What FDA’s QMSR Means for At-Home Test Kit Companies · Audit Your Specimen Kit Supplier: A Side-by-Side Criteria Sheet · AQL, Sampling Plans, and the 100% Inspection Myth
Frequently Asked Questions
Working with an ISO 13485 certified fulfillment partner means your kit assembly, storage, and distribution operations are managed within a documented quality management system that meets the international standard for medical device supply chains. This includes supplier qualification, process validation, lot traceability, environmental monitoring, and corrective action systems, all documented and available for your quality audits and regulatory submissions.
ISO 13485 certification is not universally mandated by regulation, but it is effectively required by any laboratory or diagnostic company operating under FDA oversight or distributing products in regulated markets. FDA-regulated companies are responsible for their entire supply chain, including fulfillment partners. Using a non-certified fulfillment vendor creates a regulatory gap that exposes the laboratory or manufacturer to audit findings and compliance risk.
Yes. Client audits of our quality management system are accommodated as part of our supplier qualification process. We provide access to relevant quality documentation including our quality manual, standard operating procedures, environmental monitoring records, equipment calibration logs, and CAPA records. Audit scheduling is coordinated through our quality team.
Our FDA establishment registration number is 3018077536. This registration covers our Houston facility at 3240 Fuqua St, Houston, TX 77047 as a medical device establishment engaged in kit assembly and distribution activities.
An ISO 7 cleanroom limits airborne particulate counts to 352,000 particles per cubic meter at 0.5 microns or larger, with continuous environmental monitoring to verify compliance. For aliquoting applications involving biological samples, transport media, or diagnostic reagents, this environment reduces contamination risk significantly compared to standard laboratory or warehouse settings.
Yes. Every order ships with a certificate of analysis and batch record documentation including component lot numbers, assembly records, environmental monitoring results from the production period, and final inspection sign-off. Documentation is structured to support client quality systems, regulatory submissions, and third-party audits.