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Who should attend How to prepare a 510(k) Notification and a Technical File for the CE Mark
Company CEOs and Presidents, Regulatory Affairs Managers, Quality Assurance Managers, Regulatory and Quality Assurance Professionals, Design Engineers, Quality Engineers, Legal Professionals
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Seminar Summary:

The first day of this 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products. (see full course description)

 
 
 

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Training Course Syllabus:


How to prepare a 510(k) Notification and a Technical File for the CE Mark

510(k)/CE Mark Requirements

For a new or modified medical device, product approvals are required prior to distribution. This course is intended to provide participants with a detailed list of documents and testing required for a 510(k) Notification submission to the US FDA and a Technical File for submission to a Notified Body for the CE Mark.
The first day of this 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products. The contents and rational for submitting a traditional, abbreviated and special 510(k) for a Class II Medical Device will be detailed. Labeling, Substantial Equivalence and Performance Testing for various medical devices will be detailed. In addition, the Refuse To Accept Checklist will be reviewed to help participants audit their 510(k) submissions for compliance to the checklist.
On day 2 of this course we switch gears to the EU and the requirements for the preparation of a Technical File. As an introduction, CE versus CE with a number, ISO 13485 or ISO 9001 Compliance versus Certification for a Class I device and what Annex to follow for the CE Mark will be explained. The contents of the Technical File will be detailed with examples of Essential Requirements Checklist, Clinical Evaluation Reports and Declaration s for Conformity will be presented. In addition, the key changes in the new Medical Device Directive will be reviewed.

Learning Objectives:

Upon completing this course participants will understand:
510(k) Notifications:
Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
When to file for a new device, a change in the intended use or a change in the technology of a cleared device
What is contained in a traditional, abbreviated and special 510(k) submission package
What is substantial equivalence and what’s required to show substantial equivalence
What’s required on the labeling and IFU
Which performance tests should be conducted and how to present the data to the FDA
Understand the FDA’s Refuse to Accept Policy
What is required in a submission for software controlled devices
Technical File:
Formatting a Technical File
Determine Device Classification and Conformity Assessment Procedure
Essential Requirements Checklist Requirements
Clinical Evaluation Report Requirements
Risk Management Plan and Reports Requirements
Contents of a Declaration of Conformity
Key changes in the new Medical Device Directive

DAY 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
The 510(k) regulation
Types of 510(k) submissions
Preparation of a Traditional 510(k)
Substantial equivalence
Labeling requirements
Performance testing
Substantial equivalence
Risk management documentation
When are clinical trials required
When and what’s required for a Special 510(k)
When and what’s required for an Abbreviated 510(k)
Guidance documents and FDA recognized standards
FDA’s refuse to accept policy

DAY 02(8:30 AM - 4:30 PM)

Review of the Medical Device Directive (MDD)
Technical File contents per the MDD
Determining product classification and rationale
Conformity Assessment Procedure
Essential Requirements Checklist Review
Risk Management Plan and Report Requirements
Product Information Requirements
Clinical Data Review Options
Labeling
Examples of various Declaration of Conformities

Seminar Summary:

The first day of this 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products. (see full course description)

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