Quality
Exceptional Quality Produced In Mexico
Our quality assurance is backed by our experienced team which has access to various quality assurance tools which include a state-of-the-art vision system
ISO13485 and ISO9001 Certified
ISO9001
ISO 9001 is an international standard that outlines requirements for quality management systems (QMS). It's the most widely used QMS standard in the world, with over 1.1 million certificates issued to organizations in 178 countries.
ISO13485
ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) for medical devices. It's designed to ensure that medical devices meet customer and regulatory needs, and that patient safety is maintained throughout the device's lifecycle.
Image Dimension Measurement System
Our state-of-the-art vision measuring system from Keyance helps us ensure that all your parts meet your required dimensions.
Our Quality Policy
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Consistently provide high quality products that meet or exceed the requirements and expectations of our customers through quality management, co-ordination and by pursuing molding process control.
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Follow efficient and reliable processes that are capable of meeting requirements of business. Actively pursue ever-improving quality through training programs that enable each employee to do their job right the first time and every time.
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Improve our products, processes and people through improvements based on established quality system and driving continual improvement and innovation based upon efficient business processes, well-defined measurements, best practices, and customer surveys.
Quality Experience
01.
Medical Validations OQ,IQ,PQ
02.
PPAP
03.
FDA Audit Experience
04.
RJG Master Molder II Experience
05.
DHR review/ FInish Product Testing
Medical OQ, IQ, PQ
The meaning of IQ, OQ, and PQ are installation qualification, operational qualification, and performance qualification, respectively. Our standards as set ISO13485 set them medical standards and we apply them to all our projects
FDA Audit Experience
Our experienced team has worked in the medical industry before and has experience with FDA-level audits. We follow governmental regulations and standards for the quality both in your parts and in our manufacturing process
PPAP
PPAP stands for Production Part Approval Process, a manufacturing inspection process that verifies a supplier's ability to consistently produce parts that meet customer specifications. PPAP involves inspecting parts before, during, and after production.
RJG Master Molder II Experience
With our RJG Master Molder II expertise, we are equipped to manage a wide range of projects.This expertise is dedicated to delivering the highest quality results, ensuring that every aspect of your project is handled with precision and care.