Medical Device Registration and Regulatory Submissions Know How for RA Professionals - Training Bundle

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
Construct and Manage the Technical File and Design Dossier
Creating a Good Design History File (DHF) for Audit Success
Medical Device Registration - Brazil and Argentina
EU Medical Device Directive, CE, ISO
Medical Device Classification - US and the EU as per MDD, CMDR and GHTF
Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements
Is Device Registration and Listing Stressing You Out?
FDA's Proposed Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success

The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications

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:

• Learn the differences between the Tech File and Dossier and why the construction phase is so important.
• Compile the EU Technical File or Design Dossier and ensure Format and Content expectations are addressed appropriately.
• Understand why Design Dossier is viewed as a subset of the Tech Documentation with emphasis on “design”.
• Determine exactly which materials need to be assembled.
• NB must examine the application for examination of the design dossier and, if the product conforms to the relevant provisions of the Directive, issue the application with an EC design-dossier certificate.
• Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s).
• Determine applicable standards and address company-specific SOPs for constructing and managing your files.
• European Norms and Standards and other documents supporting Technical Files and Design Dossiers.
• Guidance on Design-Dossier Examination and Report Content.

Creating a Good Design History File (DHF) for Audit Success

This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.

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:

• 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

EU Medical Device Directive, CE, ISO

This training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.

Areas Covered in the Webinar:

• The current regulatory situation in relation to Medical Devices in the EU.
• The purpose of the Medical Device Directives.
• Meeting the New Requirements for Conformity Assessment by Product Type.
• Understanding the impact the Directive will have on developing and marketing new Medical Device products.
• An overview of key areas of the Directive:
• Scope of application and definition
• Essential Requirements
• Medical Device Type & Process Path
• Medical Device Technical File
• Clinical Investigations
• Clinical Evaluations
• Notified Bodies
• Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.

Medical Device Classification - US and the EU as per MDD, CMDR and GHTF

This webinar explains the classification system in the US, the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk-based approach implemented by regulatory authorities.

Areas Covered in the Webinar:

• The Concepts of Medical Device Risk
• Factors that may impact risk
• Regulatory controls keyed to risk
• Classification in the US
• Device Class
• Device Panel
• Device type regulation
• Controls
• General Controls
• Special Controls
• Pre-market Approval
• FDA Guidance documents
• Recognized consensus standards
• Classification in the EU (MDD)
• Rule based system in MDD Annex IX
• Changes after March 2010
• Device class and the EU modules
• MDD Essential Requirements (Annex I)
• Harmonized standards
• Classification in Canada
• Rule based system in CMDR Schedule 1
• Specific requirements by device class
• GHTF Guidance
• Rule based system in the classification guidance
• Linkage to the Conformity Assessment guidance

Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements

Most Class III devices require Premarket Approval (PMA) prior to marketing the device in the United States. This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.

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:

• When and how to register and list.
• Review the four proposed changes to FDA’s device establishment registration and device listing regulations.
• Proposed changes to Implement the provision of Bioterrorism Act applicable to imported devices.
• Other proposed Amendments that would change current device establishment registration and listing requirements.
• Replacement of the current regulations regarding updating device listing information outside the required update periods.
• Clarification of who must provide establishments’ registration numbers.

Managing the IDE (Investigational Device Exemption) Submission for Compliance Success

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)’s require clinical data to support the application.

Areas Covered in the Webinar:

• Learn the appropriate and expected regulatory strategies and guidelines for your IDE.
• Application and administrative action with the IDE.
• Know the responsibilities of the sponsor.
• What records and reports are expected and required.
• IDE refers to the regulations under 21 CFR 812.
• Know the procedures involved with the clinical studies and expectations.