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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR

How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device

This webinar will focus on the application of Risk Management throughout the Product Lifecycle.

Some level of risk exists in virtually everything we do. From driving a car, to heating our homes, to ordering a meal in a restaurant, there is some level of risk. We make a decision that the benefits of our actions outweigh the risks associated.

By their very nature and application, there is an element of risk in the use of any Medical Device. Understanding, balancing, and quantifying that risk enables a manufacturer to bring a product to market that provides significant benefit to patients and health care providers, while minimizing the risks associated with the product.

This free 60-minute webinar will focus on the application of Risk Management (Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post Production Monitoring) as a product moves through the Product Lifecycle (Concept, Development, Launch, Post Market, Obsolescence).

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Specifically, this webinar will cover:
  • Risk Management as an integral part to all phases of the Product Lifecycle.
  • The Risk Management File as a living document.
  • Product Surveillance must be closed loop with Risk Management to address product issues and ensure Patient and Health Care Provider safety.
  • Ongoing Risk Management to balance Patient/Health Care Provider risks versus benefits of the Medical Device.
  • Q&A Session
Who Should Attend?
  • Medical Device Industry Executives
  • Quality Professionals and Management
  • Regulatory Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
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Hosted by

Mike Baca
Presenter: Mike Baca

President, White Rook Consulting, LLC
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Moderator: Jesseca Lyons

Senior Medical Device Guru, Greenlight Guru
About Mike Baca

Mike Baca graduated from the United States Military Academy at West Point in 1976 with a Bachelor of Science degree. He served as an Officer in the Field Artillery Branch of the US Army.

After the military, Mike joined Johnson & Johnson in 1981, working there for 22 years progressing through numerous assignments of increasing responsibility in the Quality and Regulatory disciplines through four operating companies and Johnson & Johnson Corporate as a Quality and Compliance Services Account Director responsible for Corporate oversight of several Medical Device Implant Divisions. In 2003, Mike joined Medtronic, serving as head of Quality in the Neuromodulation and later Cardiac Rhythm Disease Management divisions. He joined Stryker Instruments in May of 2010 as the Global Vice President of the Instruments Division, responsible for Quality Assurance, Regulatory Affairs, and Clinical Sciences. He retired in November 2017. He formed White Rook Consulting LLC in 2019, consulting in his areas of expertise.

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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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