Quality & Regulatory

Credentials your supply chain can verify.

Every credential is documented, available, and verifiable. Nothing is just marketing language.

Request Documentation VAC Support Kit ↓

FDA

510(k) cleared. K-numbers available on request.

ISO

13485:2016 certified quality management system

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 →

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 — and every part of it is documented and verifiable on request.

The manufacturer

A shared manufacturing source.

Manufactured by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables.

Verifiable by qualified supply chain reviewers on request.

The standards

Built to the same controls.

Manufactured to the same GMPs, particulate controls, and regulatory standards as the syringes and disposables produced by major OEMs.

Documented to recognized GMP, ISO 13485:2016, and EU MDR requirements.

The verification

Backed by documents, not adjectives.

Supplier qualification records, certificates, and conformity documentation are available to qualified buyers and VAC reviewers.

Provided alongside the full regulatory documentation pack.

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 cost comparison worksheets built around your contrast-enhanced procedure 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 contrast-enhanced procedure 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 SEVA's commercial team 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.