Medical Device Safety & Reporting Summit

Proactive Methods to Ensure Device Safety While Remaining Compliant With Established Regulations and Standards


Philadelphia, PA, United States

At the Medical Device Safety & Reporting Summit, industry professionals will gather to further enhance the knowledge surrounding the importance to maintain the quality of your medical device and ensure valuable risk management plans to pace ahead of the competition without having any setbacks. With medical device safety playing a critical role in healthcare, it is significant for organizations to ensure effectiveness by implementing a safety action plan to ensure success for the product.

Whether it is an oxygen mask, nebulizer, cardiovascular stent, medical imaging equipment, or robotics, there are certain requirements that each device must meet before going to market. While these medical devices are paramount when providing care to patients, they occasionally fail to operate OR are misused causing further harm to the patient or even death, which makes risk assessment an important juncture when developing a medical device. This event will go through in-depth details and properly arm you wish successful strategies in order to enhance product development to maintain leverage in the marketplace.

Top Five Reasons to Attend

  1. Ensure medical devices meet proper regulatory requirements and the highest quality standards
  2. Benchmark best practices and guidelines for medical device monitoring and safety with a post-approval surveillance strategy
  3. Recognize future regulation implications and ensure a successful risk management plan
  4. Allow patients to access high-quality devices with innovative strategies to maintain compliance with the FDA
  5. Essential elements of an effective corrective and preventive action (CAPA) system while maintaining compliance with reporting and documentation processes to avoid regulatory issues

Who Should Attend

  • Quality Management
  • Clinical Quality Management
  • Quality Assurance
  • Regulatory Affairs
  • Medical Affairs
  • Medical Device
  • Risk Assessment
  • Compliance/Ethics
  • Monitoring
  • Site Management
  • Site Quality
  • Research and Development
  • Project Management
  • Pharmacovigilance
  • Safety
  • Data Management
  • Real-World Evidence
  • Adverse Events/Case Management Service Providers
  • Safety Database Providers
This conference is also of interest to:
  • Healthcare/Pharmacovigilance Consultants
  • Technology Vendors

Speakers

  • Richard Arriaga, M.S., BS-Bio.,BSN, RN, Sr. Director, Head of Case Processing, PFIZER
  • Khaudeja Bano, Senior Medical Director, ABBOTT DIAGNOSTICS
  • Michael Drues, President, VASCULAR SCIENCES
  • Anupama Govindarajan, Medical Device Recall Branch Chief, U.S. FOOD AND DRUG ADMINISTRATION (FDA)
  • Michael Hunn, QA Project and Compliance Manager, DRAEGER MEDICAL INC.
  • Malik Khan, Director of Quality, STRYKER ENDOSCOPY
  • Bryan Overton, Quality Manager, DRAEGER MEDICAL
  • Sharon Perez, Director, Global Medical Safety, NOVOCURE INC.
  • Lawrence Perruzza, Director/Head, Case Investigation and Resolution, ROCHE MOLECULAR DIAGNOSTICS
  • Deva Puranam, Head of Compliance - Regional Quality, MYLAN
  • Edward Reverdy, Sr Director of Toxicology and Biocompatibility, Preclinical, JOHNSON & JOHNSON MEDICAL DEVICE COMPANIES
  • Mark Stachowski, Head of Commercial Medical Device and Combination Products, SHIRE PHARMACEUTICALS
  • Gregg Van Citters, Engineer, ADVANCED BIONICS CORPORATION
  • Weiping Zhong, Global Director, QA/RA Risk Management, Clinical Evaluation, Cybersecurity Safety, Statistics, GE HEALTHCARE

Venue

The Inn at Penn, A Hilton Hotel
3600 Sansom Street
Philadelphia, PA 19104

Discover a huge variety of Philadelphia attractions and activities within minutes of The Inn at Penn, a Hilton hotel. We're right on the campus of the University of Pennsylvania. From museums and tours to art and cultural and family attractions, there's a whole vibrant city to discover.

To make reservations please call 215-823-6240 and request the negotiated rate for ExL's March Meetings. To make reservations online Click Here

The group rate is available until March 4, 2019. Please book your room early as rooms available at this rate are limited.
Event details
Organizer : ExL Events
Venue : The Inn at Penn, A Hilton Hotel, Philadelphia, PA, United States
Event type : Conference
Reference : ASDE-19173

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