Quality / Designs Welcomes You
Quality Management Systems for Medical Device Manufacturers
Built-to-size, Custom-fit Systems that Add Value
Services
Quality/Designs was founded to manage the complex web of FDA guidances, federal regulations, and international standards for medical device quality systems. Quality/Designs precisely fit solutions to our client's needs. Our goal is to add value to our client's businesses through their quality system. We want our clients to focus on the life-saving and life-transforming medical devices they produce.
With 40 years of industry experience, our expertise in building online platforms uniquely qualifies us to design quality systems that meet your very specific needs and provide platforms that add quality to your business.
Built-to-Size, Custom-Fit
Quality Managemnt Systems Designs
Navigating the web of FDA guidances, federal regulations, and ISO13485 with its' associated standards can be overwhelming and can put your company at risk. There are many canned QMS software packages. Some can be extremely expensive to implement, time intensive to validate, costly to maintain, and force you and your company to conform to their approach rather than precisely address your needs.
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Whether you have engineers and scientists in-house or it's just you and your subcontractors, Quality/Designs will create a system to meet your exact needs. Our expertise in building custom-fit, online, certified quality systems uniquely qualifies us to:
design quality systems that meet your needs,
address applicable regulations and standards,
add value to your company.
Supporting Quality Systems Designs
Managing an existing quality management system can also be a burden and sometimes nightmarish. Services provided by Quality/Designs can ease the pressure of audits, address audit findings, and support management reviews. Quality/Designs representatives can also serve as your company's management representative as required by some standards.
Quality/Designs exists to solve the critical issues facing our clients. We provide a broad range of quality support services and solutions to help organizations achieve their vision with peace of mind.
Quality Risk Management Designs
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Quality Design History Files
Other regulatory webs our clients must deal with include risk management and design history files. For many engineers, it is the worst part of the job. We love it.
Our years of risk management and design history files support set Quality/Designs premier in the process of delivering design documents to support FDA approval and EU self-declarations.
"I have had the pleasure to work with Craig for a number of years, through several companies. His work ethic is fantastic and his knowledge of the medical device development process is a major reason he is so effective in his quality system efforts. Most recently Craig developed a custom 13485 level quality system for our medical device engineering firm, which we were able to achieve ISO certification for both design and manufacturing."
Bruce Sargeant
Groups We've Worked With:
Fusion Biotec Inc.
Get Started Now
Connect now to explore what custom-fit Quality Designs look like for your company.
Smartsheet Automagician
Recognized as one of the top 5 automation users of Smartsheet.
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Smartsheet is the platform of choice for what some have called, "the best quality management system [they] have ever used!" The platform was used to create a fully integrated quality management system that helped achieve ISO13485 certification. Quality/Designs can customize tools for your quality management system.
With full customization, we add value to your business.