Compliance Based Print Materials & Support
We offer a complete package for our customers facing regulatory requirements and challenges. Delivering effective support, solutions and best in class service, our analysis and understanding yield successfully executed projects
Who
We Are.
We are a Quality Resource Network committed to providing solutions for the Med Tech, Medical Device, and Quality Regulated Industry.
Specializing in QA controls of printed, non-printed, and integrated packaging components. Everything we do is governed in the atmosphere of ISO 13485 and filtered through the lens of Risk Mitigation Strategy.
Our Core Philosophy
Quality Output
Full diagnostic review allows us to draw a straight line from beginning to end. Understanding your project and embedding Quality Associates on the production floor, results in hard and soft dollar cost savings.
Partnership is
Personal.
Service • Support • Solutions
“Partnership is personal, much deeper than simply supplying materials, and breeds desire to achieve common goals. This is ‘our thing’, it’s what we do.”
What started out in 1989 as a 3-person operation supporting customers with printed business forms and document management, has grown into a Laser focused support partner to the largest ‘patient-first’ medical device manufacturers on earth.
1989
Established Foundation
Patient 1st
Core Industry Mission
Products
Services.
Our Core Focus is Quality By Design
Supplier Managed
Inventory Programs
We analyze forecast and demand for our clients and implement new processes for production based on immediate needs. This drives down costs and prevents unnecessary spending on obsolete materials.
Quality Input =
Quality Output
Full diagnostic review allows us to draw a straight line from beginning to end. Understanding your project and embedding Quality Associates on the production floor, results in hard and soft dollar cost savings,
Content
Control
Our team reviews and approves your Approved Content for printability to minimize errors and guarantee quality output. Risk mitigation practices are at the forefront of successful materials flowing into market.
Design &
Review Services
Dedicated design leads to effective production of print and packaging for FDA-regulated clients. We follow Quality Assurance Processes without sacrificing creativity.
Production Standards
ISO Certified
Quality Management.
We have both the certification and the expertise to meet your specifications. Our Quality Management System (QMS) is rooted in 13485 standards, implemented by an expert team.
Quality Team
Dedicated compliance experts oversee the entire process. Support, Solutions, Service.
Materials, Production Management, Inventory
CTQ data integration, parts management analysis, and annual PO notification systems.
Strategic Business Continuity
Quality Resource HUB – California, Corporate Leadership – Florida Quality Resource Network – Global.
The Front Line
Strategic
Leadership.
We operate round the corner and across the globe. Being in effective control of production processes and ensuring successful output is accomplished by Our Quality Assurance professionals being embedded at all impact areas.
Joel Mester
VP – CBP Materials
Jerad Marquez
Account Executive
Veronica Parades
Sr. Account Support Director
Desiree Gimondo
Quality Director
The Smart Accountability Process
Connect
Review Capabilities
Plan
Procurement
Execute
Production & Quality Surveillance
Warehouse
Distribution
Document
100% Quality Assurance
Do It Right The First Time.
We work with our clients on many different levels to find the best solution to meet the specific, individual project needs. We understand the cost of poor quality and we know the right way to drive successful solutions in production and distribution.
Trusted by Global Leaders
