When:
July 9, 2015 – July 10, 2015 all-day
2015-07-09T00:00:00-04:00
2015-07-11T00:00:00-04:00
Where:
Washington, District of Columbia
Contact:

In-Person Seminar and Workshop for 510(k)s and CE Mark

How to Format Succinct and Comprehensive Technical Documentations for 510(k)s and CE Mark

510k and CE Mark-In-Person Seminar

WHEN AND WHERE

  • Washington, DC: July 9-10, 2015
  • Orlando, FL: August 6-7, 2015

Venue

  • To Be Announced Later

DURATION

  • TWO (2) DAYS

PRICE

  • Day One for FDA 510(k): $599
  • Day Two for CE Mark: $599
  • Both Days for FDA 510(k) & CE Mark: $1,099

COURSE DESCRIPTION

It is imperative that medical device firms quickly recognize evolving regulatory requirements in the US and European Union (EU).  In particular, it is important to adequately understand both 510(k) and CE mark processes so that the review process can be facilitated in a proactive, effective, and streamlined manner.

This seminar will discuss both US FDA 510(k) submissions and European conformity assessment applications for CE mark. The speaker will walk you through how to format a succinct and comprehensive 510(k) including technical documentation for CE mark purposes while addressing all applicable, regulatory and essential requirements. 

This seminar will provide great opportunities to learn how to put together technical documentation for both 510(k)s and CE mark.

BACKGROUND

US FDA 510(k)

A premarket notification [510(k)] is the most common pathway to market for medical devices in the US.  The 510(k) premarket submission is made to demonstrate that the subject device (to be marketed) is substantially equivalent to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).

Over the years, there have been changes to the FDA’s 510(k) program and requirements including FDA’s issuances of key guidance documents (e-Copy, RTA policy and final 510(k) guidance). 

In order to successfully obtain marketing clearances [510(k)s], it is important to adequately put your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy. 

This seminar will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. 

The speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared. 

This session is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

This seminar will help you save your firm’s significant efforts and resources, potentially saving millions of dollars by learning actionable approaches with improved awareness and familiarity. 

EU CE Mark

This seminar will help you get familiar with the European Union (EU) directives governing medical devices (MDD) including in vitro diagnostic (IV(M)DD) and active implantable medical devices (AIMDD). This seminar will provide more practical, actionable, and sustainable guidance on the regulatory requirements set out in the three directives (MDD, IV(M)DD, and AIMDD).

Accurate understanding and adequate interpretation of the regulatory requirements for medical devices in EU can significantly help to better comply with all the applicable requirements so that compliance can be achieved in a fast pace, saving a significant amount of your time, efforts and resources and bringing innovative medical products to the EU market faster.

This seminar will offer you great insights into regulatory requirements set out in the three directives (MDD, IVDD and AIMDD) so that CE mark for your medical devices can be obtained. 

At the end of the seminar, you will become better aware of and get familiarized with the applicable EU directives governing medical devices including in vitro diagnostic and active implantable medical devices.  As a result, you can greatly help your firm better prepare a technical documentation for CE marking of your medical devices in an efficient and effective manner. 

WHO WILL BENEFIT FROM THIS SEMINAR

This seminar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologics, in vitro diagnostic devices, combination products or companion diagnostics.  It is particularly useful for those who are engaged in the design and development of medical devices, combinations products (e.g., drug and devices, biologics and devices), and in vitro diagnostic devices including companion medical products.  This webinar is a must for those who are directly or indirectly involved in handling regulatory submissions, 510(k)s to the FDA including those preparing technical documentation for CE mark to the notified bodies.

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Research and development (associates, scientists, managers, directors and VPs)
  • Product and development (associates, scientists, managers, directors and VPs)
  • Marketing (associates, specialists, managers, directors and VPs)
  • Contract manufacturing organization (associates, scientists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Senior and executive management (VPs, SVPs, Presidents, and CEOs)
  • Contractors and subcontractors
  • Compliance professionals
  • Legal counsel

SPEAKER INFORMATION

David Lim Photo.JPGDr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com), providing global and FDA consulting services in various areas of regulatory affairs, quality, clinical affairs and regulatory compliance matters.  As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings.  Recently, Dr. Lim developed 510(k) and PMA/HDE templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.  Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

AREAS TO BE COVERED

DAY ONE FOR US FDA 510(K): 9:00 AM – 4:00 PM

Morning 09:00 AM – 12:00 PM
  • Statutes and Regulations
  • 510(k) Program and Changes
  • 10(k) Regulatory Requirements
  • FDA Guidance Documents & Standards
  • How to Improve 510(k) Submission Quality
Afternoon 01:30 PM – 04:00 PM
  • Quality System Regulations
  • How to Format Succinct and Comprehensive 510(k)s
  • Submission Reviews Based on Actual Cases/Examples

DAY TWO FOR EU CE MARK: 9:00 AM – 4:00 PM

Morning 09:00 AM – 12:00 PM
  • How EU laws are made
  • Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices
  • CE Marking Principles
  • Device Classification
  • Medical Device Directive (MDD)
  • In Vitro Diagnostic Device Directive (IV(M)DD)
  • Active Implantable Medical Device Directive (AIMDD)
  • 2007/47/EC Amending MDD and AIMDD
Afternoon 01:30 PM – 04:00 PM
  • IMDRF and MEDDEV Guidance Documents
  • Harmonized and Non-Harmonized Standards
  • Clinical Evaluation and Investigation·          
  • Technical Documentation for Technical File And Design Dossier
  • Actual Cases/Examples

REGISTRATION OPTIONS

Online Registration for Washington, DC: July 9-10, 2015

  • One Attendee for Day One [510(k)]: $599
  • One Attendee for Day Two [CE Mark]: $599
  • One Attendee for Both Days [510(k) & CE Mark]: $1,099

Online Registration for Orlando, FL: August 6-7, 2015

  • One Attendee for Day One [510(k)]: $599
  • One Attendee for Day Two [CE Mark]: $599
  • One Attendee for Both Days [510(k) & CE Mark]: $1,099

Download Seminar Brochure in PDF

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In Person Seminar for FDA 510K and CE Mark
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