Customized Training Programs
Empower Your Staff with Expert Regulatory, Quality, Clinical, and Cybersecurity Solutions to Navigate Complex Challenges with Confidence
Empower Your Staff with Expert Regulatory, Quality, Clinical, and Cybersecurity Solutions to Navigate Complex Challenges with Confidence
RQMIS offers fully customized training solutions, designed specifically for your organization’s operational needs and strategic priorities.
Whether you are a medical device manufacturer, pharmaceutical company, biotech firm, or healthcare service provider, we collaborate closely with your team leaders to design training that reflects your workflows, addresses your compliance gaps, and prepares your staff to meet evolving regulatory expectations with confidence.
Our custom training programs cover a wide array of specialized expertise, including but not limited to:
Regulatory Affairs – Navigating FDA and global regulatory pathways, pre-market submissions, regulatory strategy development, and post-market compliance.
Clinical Affairs – Training on clinical trial design, protocol development, GCP compliance, and data collection best practices.
Quality Assurance & Quality Systems – Developing QMS frameworks, root cause analysis, CAPA processes, internal auditing, and supplier quality management.
Cybersecurity for Life Sciences – Addressing growing threats to digital health technologies with training on data integrity, cybersecurity risk assessments, and regulatory requirements such as FDA premarket guidance on cybersecurity in medical devices.
We understand that no two organizations are alike. That’s why our experts will assess your specific learning objectives, regulatory environment, and workforce skill levels to craft a delivery format that works for you—whether it’s live virtual sessions, on-site workshops, or blended learning modules.
RQMIS is proud to offer a series of training classes approved through the Commonwealth Corporation's Workforce Training Express Program. These courses are specifically designed to help life science professionals meet regulatory and quality requirements, optimize compliance, and enhance operational excellence.
C-13452 – Supplier/Internal Auditing 21 CFR 820 / ISO 13485:2016 / ISO 9001:2015
Gain comprehensive skills to plan, conduct, and report audits of supplier and internal quality systems. Learn to align your audits with key industry standards and FDA regulations.
C-13453 – ISO 13485:2016
Understand the essential requirements of ISO 13485:2016 for medical device quality management systems and how to implement them effectively within your organization.
C-13454 – Quality Systems Management ISO 9001:2015
Explore best practices in quality management based on ISO 9001:2015. This course strengthens your ability to manage system effectiveness and continual improvement initiatives.
C-13455 – Internal Auditing Against 21 CFR 820 / ISO 13485:2016 / ISO 9001:2015
Enhance your auditing proficiency with focused instruction on aligning audits with FDA QSR, ISO 13485, and ISO 9001 frameworks.
C-13456 – Overview and Introduction to Supplier/Internal Auditing 21 CFR 820 / ISO 13485:2016 / ISO 9001:2015
Designed for newcomers to auditing, this course provides foundational knowledge of internal and supplier auditing, including key audit principles and process understanding.
C-13457 – Quality System Regulation and Good Manufacturing Practices (QSR/GMP) 21 CFR 820
Dive into FDA's QSR requirements and GMP principles, gaining insights into how to maintain regulatory compliance throughout your quality system lifecycle.
C-13458 – Risk Management ISO 14971:2019
Learn the principles of ISO 14971:2019 and how to apply risk management throughout the lifecycle of a medical device, from design to post-market activities.
Real-world case studies and application-focused instruction
Scalable programs for teams of all sizes
Flexible delivery schedules and formats
Measurable outcomes tied to your compliance and operational metrics
Let RQMIS help you transform training from a checkbox activity into a strategic advantage.