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Speaker Profile
JOSE IGNACIO MORA

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.


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Showing 16 to 19 of 19 (2 Pages)
$200.00
Sampling Plans for Verification, Validation and Production

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
Sampling Plans for Verification, Validation and Production

This presentation shall describe how to create Sampling Plans for verification and validation, production process validation, and production control. The webinar will include the theoretical background of sampling, several examples and formulas for easy construction of sampling plans.Areas CoveredBasic Statistics The main parameters that should be considered Formulas related to SamplingSampling StandardsWho..

$200.00
IEC 62304 for Medical Device Software

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
 Download Catalog
IEC 62304 for Medical Device Software

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and no..

$200.00
Managing The Audit Function In A Global Company

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
 Download Catalog
Managing The Audit Function In A Global Company

Whether your company is small or large each should have at least one independent yet experienced individual or department that can be relied on to resolve issues from these and other perspectives: quality assurance, regulatory affairs, and corporate risk management. While companies rely on audits to remain in compliance everyone is eventually faced with a complex issue that requires examination from an..

$200.00
Medical Device Regulations in the Middle East and North Africa Region

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
 Download Catalog
Medical Device Regulations in the Middle East and North Africa Region

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. The programme will cover the regulatory requirements and developments in the individual countries such as Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, and Yem..

Showing 16 to 19 of 19 (2 Pages)