Quality Management Systems

We believe in working with our clients as a team to successfully build or improve Quality Management Systems for varied industries, so they become compliant to the regulations and minimize the risk of warning letters and fees. Our business is focused on compliance to either US FDA regulations (e.g. 21CFR Part 111, 21CFR820, 21CFR210/211, 21CFR1271) or ISO Standards (ISO 22000, ISO 9001, ISO 13485, etc.).

We help clients become compliant to the regulations or remediation of warning letters, as well as Notified Body Certifications (EU). We also perform on-site Quality Audits and diligence assessments for M&A activities. With our primary goal to be as flexible as possible and provide our services in an efficient and economical manner, most of our work is done virtually – we do not advocate on-site work unless there is no other choice. However, if you prefer for us to be on-site, we will accommodate with our vast global network of support!

Call or schedule a free consultation with our Quality Management Systems expert today!

Custom QMS Development Incorporating ERP solutions

HMI Focused Software Development

Your Quality Management System will be developed under the ISO/GMP requirements, providing active process consultation and practice audits through an immersive experience with ERP/ ISO 9001, ISO 13485, ISO 14971 implementation.

We can help build a software program using focus group evaluation incorporating Software Quality Assurance ISO 27001, and product/project management experience with various device standards.

Asset management, physical and environmental security, access control and incident management and security from increased risk of cyberattacks will all be written into the framework.

Systematic Product Development

Design for Manufacturing

Production Development Engineers with experience launching hi-tech products to a global market will provide continuous improvement in development of planning and incorporating non-conformance, corrective action and supply chain management process techniques.

You will receive decades of user knowledge experience with DFMEA, SFMEA, PFMEA, also using Design of Experiments, MEOST Life Testing and Multivariate analysis.

Our R&D pipeline consultation will prepare you for product launches and production integration, with proof-of-concept validation and testing, time to market understanding; and teams specializing in product development operations for start-ups or multinational corporations who want to tighten their practices.

Production Readiness

Post-production Surveillance

With a focus on reliability and serviceability in your production process, we can create supply chain and inventory management processes, vendor management, incoming inspection/quality control systems, and the design of jigs and fixtures.

ISO 13485 requirements for medical devices
Field service and support networks
Field problem reporting processes
Factory performance verification and warranty & installation processes

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