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Quality & Regulatory

Credentials your supply chain can verify.

SEVA Devices products are FDA 510(k) cleared, ISO 13485:2016 certified, and EU MDR compliant. Every credential is documented, every document is available. Nothing is marketing language. Everything is verifiable.

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FDA
510(k) cleared. K-numbers available on request.
ISO
13485:2016 certified quality management system
CE
Marked. EU MDR compliant. Technical files current.
Documentation Available On Request
What your supply chain team needs before approval
  • FDA
    510(k) Clearance SummaryU.S. premarket clearance. K-numbers and full summary available to qualified buyers.
  • ISO
    ISO 13485:2016 CertificateCertificate number, scope statement, and certifying body on request.
  • MDR
    EU MDR Declaration of ConformityEuropean technical documentation maintained current for all applicable products.
  • SPEC
    Product SpecificationsDimensional tolerances, pressure ratings, material composition, and sterility data by SKU.
Regulatory Credentials

Four credentials. All verifiable.

Regulatory documentation is not a marketing claim at SEVA. Every credential listed here has a document behind it. Contact us and we will send it.

FDA
510(k) Cleared
U.S. premarket clearance for all SEVA products
SEVA Devices contrast injector syringes and disposables have received FDA 510(k) premarket clearance. Clearance is product-specific and covers the full range of CT, MR, and angiography products in SEVA's current catalog.
What your supply chain receives on request: 510(k) clearance summary for each applicable product SKU, including K-number, predicate device identification, and substantial equivalence determination. Available to qualified buyers and VAC reviewers.
Request 510(k) Documentation →
ISO
13485:2016 Certified
Medical device quality management system
SEVA's manufacturing partner operates under an ISO 13485:2016 certified quality management system, the international standard for medical device design, development, production, installation, and servicing. The same standard applied to OEM injector consumables.
What your supply chain receives on request: ISO 13485:2016 certificate, certifying body identification, certificate number, and scope statement covering the applicable product lines. Available to qualified buyers and VAC reviewers.
Request ISO Certificate →
MDR
EU Compliant
European Medical Device Regulation compliance
SEVA products comply with the EU Medical Device Regulation (EU 2017/745). Technical documentation is maintained current for all applicable product lines. MDR compliance is a forward-looking credential as SEVA's international distribution expands.
What your supply chain receives on request: EU MDR Declaration of Conformity and applicable technical file summary for international procurement or regulatory review purposes.
Request MDR Documentation →
CE
Marked
European conformity marking for applicable products
CE marking indicates SEVA products meet the health, safety, and environmental requirements of applicable EU directives and regulations. CE marked products are cleared for distribution across the European Economic Area and accepted by procurement systems that require international regulatory compliance.
What your supply chain receives on request: CE mark documentation and applicable EU technical file reference for each marked product in SEVA's catalog.
Request CE Documentation →
Manufacturing Provenance

Where the syringes come from.

Manufacturing provenance is SEVA's strongest single credential. It is presented in three forms, each appropriate to its context and audience.

Public · Homepage and Product Pages
Strongest form. Used where legal exposure is lowest and audience trust is highest priority.
Manufactured by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables.
Used on: homepage, product pages, sales presentations, and general marketing contexts.
Balanced · Datasheets and Product Detail
Accurate and conservative. Appropriate for product-level documentation distributed broadly.
Manufactured by a global contract manufacturing partner trusted by leading medical device manufacturers for injector consumables and disposables.
Used on: product datasheets, brochures, spec sheets, and downloadable product documentation.
Regulatory · VAC Dossiers and Formal Submissions
Factual and precise. Calibrated for formal regulatory review and institutional procurement.
Manufactured to the same GMPs, particulate controls, and regulatory standards as the syringes and disposables produced by major OEMs.
Used on: VAC documentation packages, regulatory submissions, and formal procurement responses.
VAC Support

Everything your committee needs. Before they ask.

Value Analysis Committee reviews are won or lost on documentation completeness. SEVA's VAC support kit is ready before your committee convenes. Request it alongside your sample shipment.

01 · Regulatory

The full regulatory pack

FDA 510(k) clearance summaries, ISO 13485:2016 certificate, EU MDR Declaration of Conformity, and CE mark documentation. Organized for VAC review, not for internal filing. Arrives ready to present.

02 · Clinical

Side-by-side specifications

Dimensional tolerances, pressure ratings, material composition, sterility specifications, and particulate data for SEVA products presented alongside OEM published specifications. Your clinical reviewers see the equivalence directly.

03 · Financial

Cost comparison your finance team can defend

Transparent per-unit and per-study cost comparison worksheets built around your volume and current OEM pricing. Includes a savings estimate by modality and an unbundled pricing summary that finance can take to budget review.

Sample Evaluation

Samples ship in days. Not weeks.

Tell us your injector platform and study volume. SEVA ships evaluation samples on a timeline that fits your department's evaluation schedule, with the VAC documentation kit included. No commitment required to receive samples.

Request Samples and VAC Kit
What arrives with your samples
  • ✓ Sample evaluation protocol with load procedure, workflow notes, and technologist feedback form
  • ✓ Full regulatory documentation pack sized for VAC submission
  • ✓ Side-by-side specification sheet comparing SEVA and OEM product data
  • ✓ Cost comparison worksheet built around your volume and OEM pricing
  • ✓ Direct contact to Kim Carson, Kelley Nestor, or Janet Brown for any follow-up
Manufacturing Standards

Same standards. Same controls.

The manufacturing controls that define OEM-grade quality are not proprietary to any single company. They are codified in regulations and standards. SEVA's products are manufactured to those same controls.

  • GMP
    Good Manufacturing Practices Manufacturing processes comply with 21 CFR Part 820 (FDA Quality System Regulation) and equivalent EU GMP requirements under EU MDR. The same regulatory framework that governs OEM syringe manufacturing governs SEVA's manufacturing partner.
  • PART
    Particulate Controls Contrast injector syringes require stringent particulate contamination controls. SEVA products are manufactured and tested to the same particulate specifications applied to OEM contrast injector syringes. Particulate test data available on request.
  • MAT
    Material Composition and Biocompatibility SEVA syringes are DEHP-free. Material composition and biocompatibility data are documented per ISO 10993. Materials are selected to be consistent with OEM syringe construction for the applicable injector platform.
  • EO
    Sterilization Ethylene oxide (EO) sterilization. Single-use, sterile, validated per ISO 11135 for EO sterilization processes. Sterility assurance level consistent with OEM single-use medical device standards.
  • DIM
    Dimensional Tolerances Syringe dimensions are validated against OEM injector head specifications. Drop-in compatibility requires tight dimensional tolerances on barrel diameter, plunger travel, and connector geometry. Dimensional validation data available on request.
Request Documentation

Your VAC needs the file. We have it ready.

Request the complete SEVA regulatory documentation package. 510(k) summaries, ISO certificate, MDR declaration, product specifications, and side-by-side comparison data. Sent to qualified buyers within one business day.

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