Precision for health.
Your contract manufacturer for sophisticated medical devices
As a contract manufacturer, we realize your medical device completely in-house - from the individual sheet metal component to the tested, ready-to-assemble system in end customer packaging. Our integrated production enables us to precisely understand and reliably implement technical, logistical and quality requirements.
We supply components and assemblies that are precisely tailored to your regulatory requirements, your supply chain structures and your quality standards.
Regulatory & compliance - security through practiced standards
In medical technology, compliance is not an add-on, but a basic requirement. We work in an environment that is designed for maximum traceability and regulatory safety - and are of course certified to ISO 13485.
In this way, we fulfill the requirements for a quality management system for medical devices and create the basis for safe, auditable and regulatory robust processes.
Our expertise includes, among other things:
- UDI marking (Unique Device Identification)
- MDR / IVDR Compliance
- CE Marking Readiness
- FDA 21 CFR Part 820
- ISO 13485 Quality Management (certified)
- Design History File (DHF) support
- Seamless traceability across the entire process chain
Quality management & process optimization - quality that is measurable
We work with an understanding of quality that goes far beyond traditional inspection processes. Our systems and methods are designed to detect deviations at an early stage, analyse causes and stabilize processes in the long term.
These include:
- CAPA management
- Non-Conformance Handling
- Change Control
- Audit Readiness
- Root Cause Analysis
- Deviation management
- Supplier Quality Assurance
- Process validations (IQ/OQ/PQ)
- SPC - Statistical Process Control
In this way, we ensure that every component and every assembly is reproducible, documented and manufactured in compliance with standards.
Manufacturing & Supply Chain - integrated production for maximum efficiency
Our production is designed to realize complex medical assemblies efficiently and reliably. In addition to our forming processes and internal surface treatment, we also take on the accelerated procurement of additional components. Laser marking, functional testing and the reliable assembly of complete systems are also part of our range of services.
We support you as an OEM partner with:
- Contracted Manufacturing
- Lean Manufacturing
- Supply Chain Integrity
- End-to-end traceability
- Smart Packaging
- Cycle Time Optimization
This creates a stable, transparent and economical supply chain - from the raw component to the packaged end product.
Document management & production support - digital, traceable, auditable
Complete, digital documentation is essential for medical products. We work with systems that record all relevant production and quality data in a structured manner and provide it in an audit-proof manner.
These include:
- Electronic Device History Record (eDHR)
- Electronic Batch Record (eBR)
- Digital Work Instructions
- Shopfloor enablement
- Knowledge Management
In this way, we guarantee consistent documentation that is audit-ready and fully traceable at all times.
Your advantage: We understand your requirements
Whether technical specifications, regulatory requirements or logistical structures - we speak the language of medical technology.
With our ISO 13485-certified production, our quality culture and our understanding of compliance, we supply sheet metal parts and assemblies that precisely match 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@colsman-forming.com
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.
