As a medical device regulatory affairs professional, you play an integral role in the development of registration and submission strategy. Expertise in compiling the relevant information into Technical Files, Device Master Files, Design Dossiers, and Design History Files, as per regional regulatory standards, and a thorough understanding of the submission process can help you with speedier device inspections and clearances.
ComplianceOnline has engaged elite experts to provide deeper knowledge in regulatory strategy and submissions for you and your team in the following training bundle. This bundle is suitable for both new and seasoned regulatory affairs professionals who want to ensure compliant market entry for devices, whether through premarket notification, premarket application, or device classification.
Check out what's included in the training package
- The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications
- Creating a Good Design History File (DHF) for Audit Success
- Medical Device Registration - Brazil and Argentina
- Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements
- Is Device Registration and Listing Stressing You Out?
Each 510(k) submission poses a new set of challenges and new variations, depending on the type of device, the risk level, and its history. Therefore, it is essential to have a strong understanding of the most up-to-date 510(k) submission requirements and how they relate to your device for the most efficient submission process. This course will elaborate device classification, overview the 510(k) program, and discuss FDA submissions.
Areas Covered in the Webinar:
- Device classification as it relates to 510(k)s
- Device classification
- Overview of 510(k) program
- Content of a 510(k)
- 510(k) submission process
- 510(k) decisions
- Construct and Manage the Technical File and Design Dossier
- This webinar will discuss the difference between Technical File and Design Dossier and explain how to create them and the best practices.
Areas Covered in the Webinar:
- DHF structures that work well for audits.
- Documents that should and should not go into a DHF.
- When does a DHF need to be created.
- What to look for when auditing a DHF.
- How to address issues with the DHF.
- The usefulness of the DHF in continuing to maintain the product after launch.
- DHF ownership when third parties are involved.
- Medical Device Registration - Brazil and Argentina
- Learn how to design regulatory strategy for your medical device to expand your business in Brazil & Argentina. Get insight in to regulatory policy and implication for medical device and the key issues in medical device laws of Brazil and Argentina.
Areas Covered in the Webinar:
- Why a modular PMA.
- Modular PMA agreement with the FDA.
- Organizing each Module.
- Review time for each module.
- Manufacturing Module.
- Clinical Module.
- Class Audit of Manufacuring Facility up to 17 days.
- Is Device Registration and Listing Stressing You Out?
- This webinar will provide clarification on which medical device facility or establishment must register and list, how to register and list, and how to coordinate the payment process to accomplish the actual registration or device listing.
Areas Covered in the Webinar:
- Background of the device registration and listing
- How does registration and listing relate to MDUFMA?
- What is FURLS?
- Who must register and list?
- When are you required to register and list?
- How do you register and list?
- How do you pay your annual fee for registration?
- Do you need a US Agent? If so, what are the responsibilities of the agent?
- FDA's Proposed Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List
- Learn about the proposed Device Establishment Registration and Listing rule and how to meet the FDA requirements and expectations.
Areas Covered in the Webinar:
- Overview of challenges and opportunities in the development of business in Brazil and Argentina
- How to develop a very good and effective regulatory affairs strategy to have success in the region
- Medical Device Approval in Brazil and Argentina
- Launching a medical device in Brazil and Argentina
- Submission, renewals and variations of the marketing authorization
- Understanding how to save time and money with your RA strategy in the region
- Harmonization RA process
- Regulatory Affairs strategies
- Polices to meet the applicable regulations
- Comprehensive overview of the necessary steps of Regulatory Affairs procedures in Brazil and Argentina
- Advertisement, Techno vigilance; Documentation Requirements
- Mergers & acquisitions, large and smaller transactions
- The important legal issues to pay attention in order to get your product approval
- Legal department; multiple departments of relevant regulatory issues
- Registration submission, renewals and variations of the marketing authorization
- Best practices of preparation of documents and submission of application to the Agencies
Course Provider
Daniel O Leary,
