Technical category

ISO 9001 for medical devices

94 Companies in this category

ISO 9001 is the general quality management standard — industry-independent, widely held, and in medical technology the most common evidence among suppliers who do not place medical devices on the market themselves. It requires a process-oriented approach, leadership responsibility, handling of risks and opportunities and continual improvement, while leaving the company considerably more latitude than ISO 13485.

That latitude is also its limit. What matters in medical technology is not explicitly required by ISO 9001: traceability down to the batch, retention periods covering the product lifetime, validation of processes whose result cannot be verified, controlled documentation of design changes. A supplier certified to ISO 9001 may well master all of it — the certificate is simply not evidence of it.

For buyers this means ISO 9001 is a workable starting point for non-critical parts and services, but for critical processes it replaces neither a supplier assessment nor an audit. Many providers listed here hold both certifications side by side — ISO 9001 for the company as a whole, ISO 13485 for the medical device part.

Companies in this category

12 of 94

Supplier

Hermann Bantleon GmbH

Ulm, DE

Lubricant specialist from Ulm with around 250 employees: cooling lubricants, cleaning media, corrosion protection, VCI packaging, filter and plant technology as well as fluid management — with its own laboratory accredited to ISO/IEC 17025.

ISO 9001 · ISO 14001

Service provider

Nanofilm AM Germany GmbH

Augsburg, DE

Contract coating and surface modification: DLC coatings axyprotect® and axyprotect® MED for implants and instruments, axynit® ion implantation, patented plasmaimpax® process — ISO 9001 and ISO 13485, part of the Nanofilm Group.

CoatingSterilisationTitanium

ISO 13485 · ISO 9001

Manufacturer

Erbe Elektromedizin GmbH

Tübingen, DE

Owner-managed family business from Tübingen in its fifth generation: surgical systems for electrosurgery, gastroenterology, visceral and general surgery, gynaecology, pulmonology and urology.

ISO 13485 · ISO 9001 · MDSAP

Manufacturer

KARL STORZ SE & Co. KG

Tuttlingen, DE

Welcome to the world of endoscopy - Discover the innovative medical solutions from KARL STORZ. | KARL STORZ | Germany

SterilisationTitanium

ISO 13485 · ISO 9001 · MDSAP

Supplierchecked 23.09.2026

Cuno Stamm GmbH & Co. KG

Solingen, DE

Drop forge in Solingen since 1880: forged blanks for surgical instruments, dental and special pliers as well as scissors — certified to DIN EN ISO 9001:2015.

Forging & FormingStainless Steel

ISO 9001

Supplierchecked 22.09.2026

Bühler Metallbearbeitung GmbH

Spaichingen, DE

Family business from Spaichingen for demanding milling and mill-turning: fully machined milled parts, ready-to-install system parts and assembled units, with a focus on medical technology.

MachiningInspection TechnologyStainless Steel

ISO 9001

Supplierchecked 23.09.2026

Forécreu Deutschland GmbH

Ulm, DE

Worldwide specialist for thick-walled hollow, single-hole and multi-hole bars as well as solid bars and tubes in stainless steel and titanium — starting material for osteosynthesis screws, nails, cannulated instruments and cutting tools; since 1952, ISO 13485 and ISO 9001, German subsidiary in Saarbrücken.

Injection MouldingForging & FormingTitanium

ISO 13485 · ISO 9001

Manufacturerchecked 23.09.2026

Schmid Medizintechnik GmbH

Wurmlingen, DE

Microsurgical instruments from Wurmlingen near Tuttlingen since 1890: glaucoma punches, micro needle holders, micro scissors and micro forceps, eye and ENT instruments, plus CNC and 5-axis milled parts — ISO 9001 and ISO 13485.

MachiningTitanium

ISO 13485 · ISO 9001

Supplierchecked 03.10.2026

Herbert Keller Werkzeugbau

Dunningen, DE

Toolmaking from Dunningen in the Black Forest: stamping, injection and back-injection moulds, wire and die-sinking EDM, CNC milling, precision parts and clamping systems for EDM — ISO 9001:2015.

MachiningInjection MouldingTitanium

ISO 9001

Distribution

fillersupplies.vip

berlin, DE

Premium B2B-Großhändler für authentische Dermal Filler, Mesotherapie & ästhetische Medizin. Schnelle, zuverlässige Logistik & transparente Preise für lizenzierte Kliniken weltweit. fillersupplies.vip

ISO 9001