Precision for health.
Your Contract Manufacturer for Sophisticated Medical Devices
As a contract manufacturer, we produce your medical device entirely in-house—from individual sheet metal components to a tested, ready-to-assemble system in end-customer packaging. Our integrated manufacturing process enables us to precisely understand and reliably meet technical, logistical, and quality requirements.
We supply components and assemblies that are precisely tailored to your regulatory requirements, supply chain structures, and quality standards.
Regulatory & Compliance – Safety Through the Active Implementation of Standards
In the medical technology sector, compliance is not an added bonus, but a fundamental requirement. We operate in an environment designed to ensure the highest level of traceability and regulatory compliance—and, of course, we are certified to ISO 13485.
In this way, we meet the requirements for a quality management system for medical devices and lay the foundation for safe, audit-ready, and regulatory-compliant processes.
Our areas of expertise include, among others:
- UDI (Unique Device Identification) Labeling
- MDR / IVDR Compliance
- CE Marking Readiness
- FDA 21 CFR Part 820
- ISO 13485 Quality Management (certified)
- Design History File (DHF) Support
- Seamless traceability throughout the entire process chain
Quality Management & Process Optimization – Quality You Can Measure
Our approach to quality goes far beyond traditional inspection processes. Our systems and methods are designed to detect deviations early on, analyze their causes, and stabilize processes in a sustainable manner.
These include:
- CAPA Management
- Handling Nonconformities
- Change Control
- Audit Readiness
- Root Cause Analysis
- Deviation Management
- Supplier Quality Assurance
- Process Validations (IQ/OQ/PQ)
- SPC – Statistical Process Control
This is how we ensure that every component and every assembly is manufactured in a reproducible, documented, and standards-compliant manner.
Manufacturing & Supply Chain – Integrated Manufacturing for Maximum Efficiency
Our manufacturing operations are designed to produce complex medical assemblies efficiently and reliably. In addition to our forming processes and in-house surface finishing, we also handle the expedited procurement of additional components. Laser marking, functional testing, and the reliable assembly of complete systems are also part of our service portfolio.
As your OEM partner, we support you with:
- Contract Manufacturing
- Lean Manufacturing
- Supply Chain Integrity
- End-to-End Traceability
- Smart Packaging
- Cycle Time Optimization
This results in a stable, transparent, and cost-effective supply chain—from raw materials to the packaged end product.
Document Management & Production Support – Digital, Traceable, Audit-Ready
Comprehensive, digital documentation is essential for medical devices. We work with systems that capture all relevant production and quality data in a structured manner and make it available in an audit-proof format.
These include:
- Electronic Device History Record (eDHR)
- Electronic Batch Record (eBR)
- Digital Work Instructions
- Shop Floor Enablement
- Knowledge Management
This is how we ensure consistent documentation that is always ready for an audit and fully traceable.
Your advantage: We understand your needs
Whether it's technical specifications, regulatory requirements, or logistical structures—we speak the language of medical technology.
With our ISO 13485-certified manufacturing facilities, our commitment to quality, and our understanding of compliance, we deliver sheet metal parts and assemblies that precisely meet your requirements and reliably support your processes.
Ensure the perfect fit.
Enders Colsman INC.
Brauck 1
58791 Werdohl
Phone: +49 (0)2392 / 9782 01
Fax: +49 (0)2392 / 9782 81
Email: info@colsman2026.dgwip.de
Other specialties of Colsman.
Automotive
Colsman specializes in the production of small and medium-sized series in the automotive sector and guarantees consistently high quality and on-time deliveries with its modern management system and zero-defect strategy.
Mechanical engineering and industry
Colsman Forming is your partner for sophisticated sheet metal parts and assemblies in the industrial environment. We supply components that are technically resilient, economically producible and reliably documented - from precise individual parts to ready-to-install assemblies.
