Quality and Regulatory Compliance

Minitab evaluating drilling process for a small hole

Minitab

Naturally, quality is a critical component of life science manufacturing.  At Resonetics we understand the importance of manufacturing quality products every time, on time.

We emphasize total customer satisfaction, continuous improvement and defect prevention through a robust, data driven, QSR and cGMP (current good manufacturing practices) compliant world-class quality system.

ISO 13485:2003 and 9001:2008 Certified

Resonetics' ISO certifications give customers confidence in our contract manufacturing quality systems.  These certifications are a critical part of our infrastructure that supports our focus on manufacturing  components, sub-assemblies, and devices for the medical device and diagnostics industries, leveraging our core capability of laser micromachining polymers.

View our ISO 13485 certificate.
View our ISO 9001 certificate.

Production Development Process 

Resonetics uses a robust and proven six-phase medical device production development process that complies with the quality system requirements of FDA 21 CFR 820, ISO 13485, ISO 9001, and ISO 14971 (risk management).

Our production development process will provide the framework to manage your project throughout all phases of the project: design and development, verification and validation, design transfer, and commercial production. We will also customize it to meet your own quality system requirements.

Real time statistical process control

Real-time SPC

Real Time Process Capability and Feedback

At Resonetics, we don't settle with trying to catch defects at final inspection; we're proactive to prevent defects and build it right the first time to ensure total customer satisfaction.

Real time Statistical Process Control (SPC) is one of the tools we use during manufacturing that helps us make intelligent decisions to improve manufacturing robustness in real time before defects occur, while eliminating human error due to measurement technique.

Real time SPC  enables us to identify, control and eliminate variation while reducing  scrap, rework and down time, as well as other costs due to returns, warranty or liability issues.

SmartScope measuring system

SmartScope

SmartScope® Measuring Systems

Manufacturing components with feature dimensions down to a couple of microns requires sophisticated metrology tools. We use SmartScope measuring systems with our laser micromachining processes to ensure we get it right every time. These video metrology systems are accurate and fast, allowing us to maintain the highest levels of quality without incurring higher costs.

Minitab® Statistical Software

To help improve quality, Resonetics uses Minitab statistical software.  This software helps us make the most effective use of data, and therefore make the most informed decisions, which, in turn, help us improve process control, resulting in higher quality, reduced waste and lower costs.

Six Sigma Black and Green Belts

Six Sigma Principles

We believe that in the manufacturing of devices for the medical and diagnostics industries, there simply is no room for a product that doesn't meet the highest standards for quality.  We employ engineers who are Six Sigma Black Belt certified to help further reduce waste and inefficiency in our processes, and to make sure your expectations are met. We have also begun a new training program internally to develop green belts, the first step in becoming certified to the Six Sigma principles.

Operational Excellence (OpX)

In support of our customers' needs, we have evolved our Six-Sigma program into an Operational Excellence business model that combines the toolsets of Lean and Six-Sigma to drive process improvements throughout Resonetics.  We first enable and then empower our employees, including our process experts (operators), in support of all Operational Excellence process improvement activities.   

In our visual factory we continuously monitor all critical business metrics inclusive of the customer satisfaction metrics of outgoing quality and on-time delivery, deploy 5S+1(safety) practices, and establish continuous improvement teams to facilitate quality improvements, one piece process flow and cost reductions.  Utilizing the Six-Sigma discipline of the DMAIC process, we drive all improvement activities to root cause and correction.

 

SmartScope® is a registered trademark of Quality Vision International, Inc., the parent company of Optical Gaging Products, Inc.MINITAB® is a registered trademark of Minitab, Inc.