Quality Knowledge. Quality Systems. Quality Devices.
Medical device quality system training is continuous and essential for getting on the fastest path to commercial success. Lean into our expertise in quality management systems (QMS) to advance your medical device quality and regulatory strategy. As a leading regulatory, quality assurance, and microbiology consultant in the medical device industry, QA Consulting bridges the knowledge gap and provides comprehensive solutions for early-stage and established organizations. Our QMS training is designed to address the challenges medical device companies face in achieving regulatory compliance and maintaining high-quality standards.
Benefits of QA Consulting’s Medical Device Quality Training
Working with QA Consulting for medical device quality system training provides you with the benefits of their expertise, customized solutions, updated documentation, and comprehensive training and support, helping you establish a robust QMS that meets regulatory requirements and ensures quality in your medical device operations.
- Better understand the standards and certifications your QMS must comply with to successfully execute your FDA strategy or MDR strategy
- Receive guidance and actionable insights through a gap analysis that indicates the quality assurance knowledge gaps and document control needs
- Develop a robust QMS that paves the road to success
- Get a QMS documentation package, learn the need of various documents, how to use and maintain them properly, and keep them organized and accessible
- Select, validate, implement, and maintain the electronic QMS (eQMS) that suits your business workflow and regulatory strategy
By leveraging our quality system services, QMS expertise, and ongoing training, your organization can achieve ISO 13485 certification, address FDA 483 observations, and mitigate risk from device design through post-market activities.
“What I appreciated is the breadth of services that QA Consulting, Inc. provided, including expertise with Grand Avenue Software. They offered quick and efficient QMS SOPs, and were pleasant to work with.”
– Diane Keyser, Sr. Quality Engineering Consultant
Updating QMS for Complex Organizations to Comply with FDA Findings and Updated Standards
Larger organizations with complex medical device operations may face challenges in maintaining their QMS in compliance with FDA requirements. QA Consulting offers a solution by providing customized updates to address FDA findings and regulatory changes. We assist in updating procedures, documentation, and processes, and provide comprehensive training to ensure effective implementation. With our expertise in FDA regulations and remediation strategies, QA Consulting helps larger organizations proactively address compliance gaps and maintain a robust QMS.
Supporting Business Workflow Expansion with Updated QMS
Expanding business operations, such as incorporating cleanroom workflows for sterilization, will require updates to the QMS of medical device companies. QA Consulting provides customized QMS services and training to accommodate business workflow expansion. We guide clients in updating procedures and eQMS and provide comprehensive training to ensure a smooth transition throughout the organization. Our tailored solutions help clients maintain compliance and high-quality standards as their operations grow.
Bridging the Knowledge Gap for Startup Medical Device Companies
Startup medical device companies often struggle with the complex regulatory landscape and need the expertise to develop a robust quality management system (QMS). QA Consulting performs a thorough gap analysis and offers QMS packages with comprehensive documentation and training on using, maintaining, and updating quality documents.
We also assist in selecting the right eQMS software and provide validation and qualification support, and user training. Our expertise bridges the knowledge gap, empowering startups to establish a strong foundation for regulatory compliance and mitigate legal consequences of FDA non-compliance throughout the commercialization journey.
The QA Consulting Advantage
With over 100 years of combined experience and approximately 350 successful partnerships with medical device manufacturers, we excel at simplifying complex, time-consuming medical device quality assurance training. Our team of experts has in-depth knowledge of regulatory requirements, certifications, quality documentation, and eQMS software.
“QA Consulting, Inc. was instrumental in bringing CryoLife’s mechanical heart valves to market. Their expertise directly related to our devices enabled them to hit the ground running without extending our project timeline. They helped us reduce the engineering time needed and shortened our timeline for FDA approval. The quality and regulatory expertise of the QA Consulting team is unparalleled.”
– Jeff Stark, Principal Process Engineer, CryoLife
Recommended QMS Resources and Training
- MedTech Startup Guide to Quality Systems
- A Medical Device Quality Standards Primer
- ISO 13485 Requirements and Medical Device Audits
Ready to enhance your QMS and achieve regulatory compliance? Contact us today to learn more about our QMS training and consulting services. Schedule a consultation with our experts to discuss your specific needs and challenges in the medical device industry. We are here to help you succeed!