Phone: 435-414-0115
NovaQual is a catalyst of real, actionable solutions for FDA & ISO governed companies. NovaQual software and consulting services create efficient processes that your business can implement and benefit from immediately. Our systematic approach allows us to quickly assist your company grow to be a stronger leader in your respective industry, by providing solutions that maximize productivity and simplify industry and regulatory requirements.
We specialize in optimizing your processes during the entire business lifecycle and inflection points, start-up or emergence, rapid growth, maturing, reinvention, divesting, merging or acquisition, and remedial action by regulatory or industry bodies.
For a business to successfully enter a competitive marketplace, such as that of medical device manufacturing, it must first excel in keeping its own business organized. By establishing, implementing, and maintaining a quality management system (QMS), businesses will eliminate internal operating issues and carve out a clear, standardized path to success. For many businesses just starting off, or those that have reached a critical inflection point, it may be difficult to step back and assemble a QMS system. Let us help you simplify complex regulations into an easy-to-understand quality system using our software or business and regulatory acumen.
NovaQual - Consulting
Regulations (FDA / ISO)
Process Improvement
Lean Methodology
Project Management
Statistical Process control
Validations
Quality Assurance
Quality Control
Title 21 CFR Part 820
Title 21 CFR Part 11
ISO 13485
ISO 9001
ISO 14971
With complementing talents in technology, process improvement and regulatory compliance, our consultants offer hands-on experience optimizing your business systems. We are experts in technology solutions, FDA Quality System Regulations (Title 21 Code of Federal Regulations Part 820 & Part 11), and ISO standards of Quality Management System (QMS) for medical devices (13485), risk management (14971) and general quality management (9001). Our consultative partnership model creates simple, repeatable and systematic business processes that improve product quality and delivery, compliance and profitability, serving the areas of FDA regulated and ISO governed companies around the globe.
Let our consultants provide the talent, knowledge and expertise to assist your business develop and maintain personalized quality management systems, policies, and procedures; thus, meeting FDA requirements and achieving industry certifications with reputable ISO registrars.
NovaQual - Software
NovaQual software team provides multi-functional software solutions for servers, web, or personal computers. Each product streamlines business processes and compliance. NovaQual understands each regulatory requirement in the regulated field, and assists clients in understanding the big picture process. NovaQuals software streamlines the path to compliance by removing steps that do not add value. Additionally, NovaQual automates and enhances those steps that do add value by providing user-friendly, cloud-based software. NovaQual partners with clients to create a consultative partnership and improve marketability during each inflection point of their business. Each NovaQual software product is updated regularly to reflect current regulatory and industry requirements.
Let us assist your regulated company implement a world-class quality management system (QMS) with current released software for the industries of Medical Device (ISO 13485), Manufacturing (ISO 9001), and the Interoperability Standard for Industrial Automation & Other Related Domains (OPC Foundation).
