Regulations for Medical Device Development Workshop by Tonex
This comprehensive workshop by Tonex provides an in-depth exploration of the regulatory landscape governing medical device development. Participants will gain a nuanced understanding of the complex regulatory framework, ensuring compliance and successful product commercialization. Through real-world case studies and expert-led discussions, attendees will navigate the intricacies of regulatory requirements to streamline the development process.
The Regulations for Medical Device Development workshop by Tonex offers a comprehensive exploration of the intricate regulatory landscape governing the entire life cycle of medical devices. This intensive training equips participants with the knowledge and skills necessary to navigate global regulatory frameworks, ensuring compliance with standards such as FDA regulations and the EU Medical Device Regulation.
Through real-world case studies and expert insights, attendees will gain a strategic understanding of risk management, efficient documentation, and seamless post-market compliance. Ideal for regulatory affairs professionals, quality assurance specialists, and R&D teams, this workshop is an indispensable resource for those striving for excellence in medical device development.
Learning Objectives: Upon completion of the workshop, participants will be able to:
- Understand the global regulatory landscape for medical devices.
- Interpret and apply key regulations throughout the product development lifecycle.
- Implement strategies for efficient regulatory submissions and approvals.
- Mitigate risks associated with non-compliance through effective regulatory management.
- Incorporate regulatory considerations into the design and development of medical devices.
- Foster collaboration between regulatory affairs, R&D, and quality assurance teams for seamless compliance.
Audience: This workshop is tailored for professionals involved in medical device development, including:
- Regulatory Affairs Specialists
- Quality Assurance Professionals
- R&D Engineers and Scientists
- Product Managers
- Clinical Affairs Specialists
- Compliance Officers
Course Outline:
Introduction to Medical Device Regulations
- Overview of global regulatory agencies
- Key regulatory milestones in medical device development
- Impact of regulatory compliance on market access
FDA Regulations and Compliance
- Understanding the FDA regulatory framework
- Navigating the 510(k) and PMA processes
- Preparing for FDA inspections and audits
EU Medical Device Regulation (MDR)
- Overview of the EU MDR requirements
- Transitioning from MDD to MDR
- Unique challenges and considerations for EU compliance
Risk Management in Regulatory Compliance
- Implementing risk management strategies
- Addressing and mitigating common compliance risks
- Integrating risk management into the development process
Regulatory Documentation and Submissions
- Creating effective regulatory documentation
- Best practices for regulatory submissions
- Responding to regulatory queries and feedback
Ensuring Post-Market Compliance
- Implementing post-market surveillance strategies
- Handling complaints, recalls, and adverse events
- Continuous improvement and adapting to regulatory updates