Quality
Quality is always our focus at Freudenberg Medical.
We work closely with our customers to implement customized validation and quality assurance systems. Our objectives are to ensure compliance with all FDA, ISO, MDR and customer requirements.
Our dedication to quality encompasses:
- ISO Class 7 and 8 controlled environments
- FDA registered manufacturing facilities in the United States, Costa Rica, Germany, Ireland, and China
- ISO 13485:2016 certification
- ISO 14001:2015 for environmental management system
- ISO 45001:2018 for occupational health and safety management system
- GMP and QSR compliant globally
- European MDR 2017/745
- MDSAP Health Canada
- Regulatory 510(k) and CE submittal process
- Climate-controlled metrology laboratory
- Test method development, first article inspections, Gauge R&R
Our products and services meet the highest quality standards for the health and safety of patients. Global Quality Management System MasterControl ensures compliance, standardized information processing, change control, and training documentation.
Our audit record is exemplary:
15 audits by government authorities and notified bodies in 2024 and 100% of all audits without major observations. We have metrology capabilities for automated inspection routines providing accurate and trending data for customers.
Quality & ISO Certificates
Products are manufactured at our 12 global ISO 13485 certified medical device facilities in ISO class 7 and 8 cleanrooms. Click the site name below to access ISO certifications and registrations.
Aachen, Germany (Hemoteq)
FDA registered
Kaiserslautern, Germany
FDA registered
Carrick-on-Shannon, Ireland
FDA registered
Shenzhen, China
FDA registered
Yaita, Japan (Fuji Seiko)
Carpinteria, CA, USA
FDA registered
Jeffersonville, IN, USA
FDA registered
Minnetonka, MI, USA
Beverly, MA, USA
FDA registered
Baldwin Park, CA, USA
FDA registered
Coyol, Costa Rica
FDA registered
T.I.M.E.TM
The corporate-wide T.I.M.E.TM (Thermoplastic Injection Molding Excellence) initiative maximizes consistency and quality of precision molded components for customers.
Speed to
Production
We focus intensely on establishing and maintaining the most stable processes that shorten NPI so production begins sooner.
Fewer Component Defects
We are students of the material. Our proprietary approach allows us to minimize short shots, weld lines, burns, blush, flashing and other defects.
Consistency Between Runs
Our obsession with testing and recording of results allows us to reliably “dial in” part repeatability, the first time and every time.
Proactive Process Culture
We don’t engage in an endless cycle of “trial and error” on setup for every run. Our team is trained to closely follow our proprietary best-practice procedures.
In medical device manufacturing, producing a good part once isn’t the goal—producing it perfectly, every time, is. True quality means going beyond trial and error to deeply understand and control the process. That’s what our customers—and their patients—rely on.
Doug Thorpe
Senior Director of Process Technology & Engineering
The T.I.M.E.TM initiative is led by Doug Thorpe, Senior Director of Process Technology & Engineering with +40 years of experience in precision injection molding. Read on about how to optimize your medical injection molding process to prioritize quality in Plastics Today: How to Optimize Your Medical Injection Molding Process
Focus on the process of making consistent components and tubing
To ensure maximum quality and consistency for our customers, we optimize every step of the process:
Part design and design for manufacturability
Material selection
Mold design
Equipment and machinery
Processing with best practices and best tools
Consistent measurement
Post-mold handling
