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Ecoclean Group US Highlights MDR- and FDA-Compliant Cleaning Solutions for Medical Device Manufacturers

Ecoclean Group US outlines its validatable, MDR and FDA-compliant parts cleaning solutions for medical device manufacturers, supporting audit-ready processes from pre-cleaning through final cleaning and passivation.

SOUTHFIELD, Mich. – November 2026 — Ecoclean Group US, the North American subsidiary of the SBS Ecoclean Group, today highlighted its industrial parts cleaning solutions for the medical technology sector, developed to meet MDR and FDA quality requirements across the full production process, from pre-cleaning through final cleaning and passivation.

Medical device manufacturers face cleaning requirements that go beyond visible cleanliness. Implants, surgical instruments and endoscopy components must meet documented, reproducible cleanliness specifications that hold up under regulatory audit. Ecoclean's systems are engineered around this requirement, supporting process development from Pre-PQ through Installation Qualification, Operational Qualification and Performance Qualification, with fully traceable documentation for components, software and process data.

Read More about the Medical Technology Industry: https://ecoclean-group.us/industries/medical-technology/

The company's medical technology process chain spans across single-chamber aqueous and solvent-based pre-cleaning after CNC machining, ultrasonic immersion cleaning after grinding and polishing, and ultrasonic batch immersion systems using Pulsated Pressure Cleaning vacuum-pressure technology for final cleaning and passivation. Vacuum-assisted processes are engineered to reach capillaries, blind holes and other complex geometries common in implant and instrument manufacturing.
To support quality assurance and validation, Ecoclean's medical technology customers have access to EN 10204 Type 2.1 certificates for media-contacting components, calibratable sensors aligned to international standards, and testing through certified partner laboratories covering particle analysis, film-type contaminants, bioburden and endotoxins.

Manufacturers can validate a cleaning process under real production conditions through Ecoclean's medical technology test centers in Dettingen and Monschau, Germany or at the Technology Center in Warsaw, Indiana, a center of excellence for cleaning and packaging developed in a partnership between Ecoclean and EnPak LLC. The Warsaw location sits within one of the largest orthopedic and medical device manufacturing regions in the world and combines high-purity parts cleaning with downstream packaging, inventory and logistics services under vrey stringent requirements.

"Manufacturers in this industry cannot treat cleaning as a final visual check," said a company representative. "It has to be a documented, repeatable process that holds up under an FDA or notified body audit, and that has to be proven before it reaches the production floor."

Ecoclean Group US, headquartered in Southfield, Michigan, engineers, manufactures, sells and services its own parts cleaning equipment in the United States and Mexico as part of Ecoclean North America, which also includes SBS Ecoclean México, S.A. de C.V. This local capability is backed by more than 60 years of parts cleaning, deburring and surface treatment engineering from the SBS Ecoclean Group, which operates in 12 locations across 10 countries.

Manufacturers evaluating cleaning processes for implants, surgical instruments, endoscopy components, or 3D-printed medical devices can schedule a feasibility trial through Ecoclean's medical technology test center network.

About Ecoclean Group US:
Ecoclean Group US, headquartered in Southfield, Michigan, is the North American subsidiary of the SBS Ecoclean Group, a global manufacturer of industrial parts cleaning, deburring and surface treatment systems with more than 60 years of engineering experience across 12 locations in 10 countries. Ecoclean Group US engineers, manufactures, sells, and services its own parts cleaning equipment for manufacturers across the United States and Mexico, serving industries including automotive, medical technology, aerospace, semiconductor and high-purity/high-tech manufacturing. Learn more at ecoclean-group.us.

Media Contact:
Ecoclean Group US

Address: 26801 Northwestern Highway, Southfield, MI 48033

Phone: +1-947-272-0600

Email: info.usa@ecoclean-group.net

Media Contact

Ecoclean Group US

Ecoclean Group US

26801 Northwestern Highway, Southfield, MI 48033, USA, Southfield, Michigan (MI)

+1 947 272 0600

https://ecoclean-group.us/

Topics: Industrial Parts Cleaning Machine Ultrasonic Cleaning Machine Solutions Medical Technology Industry
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