ISO 13485:2016 CERTIFIED | WOMAN OWNED BUSINESS | FDA REGISTERED
QUALITY
At D&R Products, quality is not just a requirement—it is a fully integrated discipline embedded in every stage of our manufacturing process. We adhere to the most rigorous industry standards to ensure the safety, performance, and regulatory compliance of every component we produce, particularly for mission-critical medical device applications.
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Comprehensive Quality Management System
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The cornerstone of reliable manufacturing is a robust and precise system of measurement. At D&R, we have implemented a company-wide quality infrastructure built on disciplined measurement, documentation, and continuous improvement. All personnel receive thorough training in the proper use of precision measurement instruments, ensuring consistency and accuracy in every operation. Our metrology program includes routine surveillance, traceable calibration, and preventive maintenance of all inspection equipment—supported by strict documentation and audit trails.​
​Our commitment to quality is backed by the following certifications and compliance standards:
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ISO 13485:2016 Certified – Our Quality Management System meets international regulatory requirements for the design and manufacture of medical devices, with a focus on risk management and traceability.
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FDA Registered – We are registered with the U.S. Food and Drug Administration, maintaining current good manufacturing practices (cGMP) in line with 21 CFR Part 820.
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GMP Compliant – Our operational processes follow stringent GMP guidelines to ensure cleanliness, product integrity, and process repeatability throughout production.
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In-Process Quality Control & Inspection
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We employ real-time, in-process inspection protocols to detect and resolve variances at the earliest stages of production. This includes:
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First article inspections
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Dimensional checks using calibrated digital and optical instruments
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Attribute sampling and statistical process control (SPC)
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Robust Quality Documentation & Validation Protocols
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To support transparency, repeatability, and regulatory readiness, we generate and maintain comprehensive quality documentation, including:
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Process Capability Studies (Cpk Analysis): To confirm manufacturing consistency and tolerance conformance across production batches.
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Risk Analysis (PFMEA): Proactive failure mode and effects analysis to identify and mitigate potential process risks before production begins.
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Control Plans: Detailed documentation of process parameters, inspection points, and response actions for each product.
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Process Mapping: Visual workflows that outline each step of the manufacturing process for optimized quality control and traceability.
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Process Validation: IQ/OQ/PQ protocols to ensure that every process consistently produces parts that meet pre-defined specifications and regulatory requirements.
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Customer-Specific Documentation and Reporting
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D&R Products is equipped to deliver customized quality documentation packages tailored to your regulatory or internal quality assurance needs. Whether you require specialized inspection reports, custom validation protocols, or product-specific documentation, we work closely with your quality team to meet exact specifications and support your compliance efforts.
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By combining precision measurement, rigorous training, real-time quality control, and regulatory-driven documentation, D&R Products delivers a turnkey quality system built for the demands of today’s medical device and advanced manufacturing industries.
