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Top 2 Medical Device Conferences to attend in November 2013

11/7/2013 9:00 AM - 11/8/2013 6:00 PM

Date, Venue and Price:

Location: Philadelphia | November 7th & 8th, 2013 | 9 AM to 6 PM EDT

Venue: DoubleTree by Hilton Hotel Philadelphia Center City

Address: 237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA

Price: $1,295.00

2-day In-person Seminar on “Applying ISO14971 and IEC62304 - A guide to practical Risk Management” at Philadelphia


This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate activities to cover all three requirements documents is presented.

Who Will Benefit:

1. Project Managers

2. Regulatory / Compliance Managers and Specialists

3. Quality Assurance Managers

4. System Engineering

5. Hardware Engineers

6. Software Engineers

Instructor Profile:

Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

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2-day In-person Seminar on “How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process” at Philadelphia

Summary: This two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

Who Will Benefit:

1. CEOs &CFOs in medical device companies

2. VPs, Directors and Heads of Regulatory Affairs

3. VPs, Directors and Heads of Clinical Affairs

4. Senior and line Marketing and Sales Management

5. Regulatory Consultants

6. Risk Managers

7. Engineering & R&D

8. Professionals involved with premarket notification to the FDA

9. R&D personnel involved in approving the design of medical devices

10. Medical device sales and marketing personnel

11. Production & Operations

Instructor Profile:

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

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Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884





NetZealous LLC

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

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