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about us
Quality & Regulatory Compliance
The Standards That Drive Excellence
At DCN Dx, we are defined by uncompromising quality and unwavering regulatory adherence. Our robust Quality Management System (QMS) ensures every product we develop and manufacture meets the highest benchmarks for safety, reliability, and compliance. By embedding globally recognized standards, such as ISO 13485 and FDA Title 21 CFR, into our processes, we deliver diagnostics that our clients—and their regulators—can count upon.
Quality &
Regulatory Standards
DCN is certified to ISO 9001:2015 Quality Management System – requirements and ISO 13485:2016 Medical devices – Quality management systems – Requirements.
| CERTIFICATE NO | REGISTRATION NO | VALID UNTIL |
| ISO13485:2016 | 10005054 MP2016 | 02 MAY 2029 |
| ISO9001:2015 | 10005054 QM15 | 23 APR 2029 |
Additional standards and regulations followed by DCN Dx:
- U.S. Food and Drug Administration – Code of Federal Regulations Title 21
- Current Good Manufacturing Practices (cGMPS)
- IEC 61010 Safety requirements for electrical equipment for measurement, control and laboratory use
- IEC 62304 Medical device software-life cycle processes
- EU MDD and IVDR requirements as we expand our scope of products and services
- ISO14971 Risk Management
Our Commitment
to Quality
Our Quality Management System integrates every aspect of product development and testing. This ensures that we meet and exceed regulatory requirements across various diagnostic platforms. Whether working on early-phase clinical research or scaling manufacturing processes, we focus on risk management, traceability, and continual improvement to maintain the integrity of the products we develop.
Adhering to
Regulatory Standards
DCN Dx adheres to global standards, including ISO 13485 and ISO 9001 certifications, ensuring our processes are robust, compliant, and scalable. Our expertise spans FDA Title 21 CFR compliance, cGMP requirements, and risk management systems like ISO 14971, all designed to mitigate risk and streamline regulatory approvals.
Supporting Documentation
and Audits
For each project, we provide comprehensive documentation, including design history files, certificates of analysis, safety data sheets, and quality agreements. Our team will work closely with you to navigate audits, ensuring compliance and transparency throughout the process.
Supporting Your
Regulatory Documentation
We recognize that each of our clients operates in a distinct regulatory environment, with unique documentation requirements. Our Quality team works to ensure you have the precise documentation needed for your products and services, supporting compliance at every phase.
.01
Design history files (technical files) for client design and development projects
.02
Certificates of Analysis or Conformance
.03
Specification Sheets
.04
Safety Data Sheets
.05
Supply Chain Information
.06
Copies of Certificates ISO9001:2015 and ISO13486:2016
.07
Site Audits
.08
QMS Self-Assessments Questionnaires
.09
Quality Agreements
.10
Quality and Change notification agreements
.11
Quality declarations i.e. Certificates of Origin, Animal Origin