Daniel O'Leary
President, Ombu Enterprises, LLC
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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Recorded Webinar
Acceptance Activities in FDA's Quality Management System
FDA Warning Letters frequently cite acceptance activities, suggesting that device manufacturers may have implementation problems. This section is in the top ten Warning Letter citations. To avoid a 483 and a Warning Letter, you must understand the QSR requirements and implement them. This presentation explains the regulation, guides you to take action, and uses Warning Letters to illustrate problems.
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Developing an Effective Risk Management Plan for Medical Devices
This presentation gives you the essential information to write a successful Risk Management Plan. Don't skip required items or add additional, but unnecessary information. If the item doesn't apply, so why. Don't include extraneous information such as market size and share; they are not relevant. The Risk Management Plan is key for an efficacious project that helps to ensure your device is safe and meets the regulatory requirements.
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Kano Analysis for Product Decisions
Kano Analysis, an important tool for product development, uses a structured methodology to help determine important device characteristics. For example, if customers expect a device will have a certain feature, they would be disappointed if it isn't there. However, if it were there, it doesn't create satisfaction; it was assumed.
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Usability Engineering in IEC 62366-1:2015 - Implementing the New Standard
This audio conference provides the explanation you need to help implement the new IEC 62366-1:2015 standard. It provides details on the new concepts, highlights the many revised definitions, and provides a conceptual model to help you understand the approach. For example, the audio conference uses examples to illustrate use error and its relationship to hazards and harms.
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MDR Procedures - The Required Content
All medical device manufacturers marketing in the United States must have procedures for reporting adverse events to the FDA. This applies regardless of where in the world the company manufactures the device. During an FDA Inspection, the investigator will ask for the procedures and verify that they follow the regulation. This includes linking the MDR information to complaints and reporting to FDA. Failure to implement the MDR regulations properly is one of the most common problems cited in Warning Letters. It comes just below the complaints and corrective and preventive action, both of which are often related.
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Device Accessories - Understanding and Implementing the Final Guidance Document
The classification of device accessories has a high visibility. For example, the 21st Century Cures Act, signed into law in December 2016, amends the FD&CA to include accessory classification. It is very important, as a result, to apply the guidance document to your firm's products to determine if any of them are an accessory and as a result, ensure they meet the device regulations.
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Data Analysis in QSR
Data analysis is one of the most powerful improvement tools because it can lead to cost reductions and preventive action. To use these techniques you need to know both the regulatory requirements and the analysis framework. This presentation provides that essential information.
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Statistical Concepts of Process Validation
If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material. This presentation provides the background you need on the statistical approach to process validation.
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Risk Management Using ISO 14971:2007 and EN ISO 14971:2012
Risk management is essential to device design and required by other standards, such as usability engineering, biocompatibility and electrical safety. The basis is ISO 14971:2007, but many companies don't understand the standard, don't follow the process flow, and consequently don't have an effective implementation. This presentation helps you avoid the common problems and create a compliant system.
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Setting and Measuring Quality Objectives
The Quality Objectives, derived from the Quality Policy, must be measurable. Good metrics have characteristics that make them clear and understandable. This presentation describes three types of metrics, illustrates how to use them for the Quality Objectives, and provides examples developed using Excel. One of the metric types, related to cycle time, has a particularly interesting graph type available in Excel.
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Sampling Plan for Quality Audits
Quality audits provide assurance to management that the quality system operates effectively. Part of the audit evidence is the records examined. There is a balance, since too few records may mean missing an issue, but too many may not be a good use of resources. This presentation provides the information you need to use in sampling for quality audits.
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Using Analysis of Variance(ANOVA) - A Practical Approach
This webinar provides a powerful statistical tool called Analysis of Variance (ANOVA) that you can use to analyze data and improve processes. Because the tool is available in Excel, you don't need to purchase an expensive complicated software package. It is already available to you.
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Understanding and Implementing the EU Vigilance System
This webinar provides the information you need to understand the Vigilance document. It explains the various requirement including adverse event reporting, recall notification to regulators, recall notification to customers, trending analysis for complaints, and other areas covered.
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Updating the Risk Management File for EN ISO 14971:2012
The content deviations in Medical Device Directive and Risk Management Standards continue to create confusion and implementation problems. This webinar helps you analyze them and understand the connections between the MDD and the Risk Management standard. It also provides specific recommendations on how to update an existing risk management file and tips for creating a new one.
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Acceptance Sampling by Variables
This webinar explains the methods in Z1.9 and shows how to use it in a modern setting. Participants learn the modern methods based on any simple statistical calculator that can provide the mean and standard deviation of a data set. Excel is also a good tool for this application.
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Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012
The ISO 10004:2012 model has four major elements in the customer satisfaction process: Identifying customer expectations, gathering data, analyzing the data, and communicating the information. The webinar explores each element and explains its application. The webinar also discusses the difference between a complaint in the regulatory realm and a complaint involving only customer satisfaction.
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Clinical Evaluation and Risk Management
Medical devices sold in the European Union fall under the Medical Device Directive (MDD). The webinar includes a discussion of clinical evaluation, including the recommendations from MEDDEV 2.7-1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. The webinar also covers MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up.
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Design Change Analysis - Five Considerations
Design changes are an important part of any medical device manufacturer's quality management system. It provides the mechanism to bring improved devices to market and fix problems with existing designs. Device manufacturers need an integrated system to handle design changes. In addition to the change itself, this system must include other parts of the regulations. If they apply, implement them. If not, create a quality record that explains the decision.This webinar explains these considerations and provides the information you need to stay in compliance.
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Corrections and Removals - Understanding and Implementing the Final Guidance Document
Making changes to product in the field can raise some regulatory hurdles for device manufacturers. One issue, for example, is determining when a design change should include a field action. The regulations are not always clear, especially when reviewing Part 806 which can lead to recall action under Part 7. The definitions in these parts don't even agree. FDA had been concerned that companies would not enhance medical devices for fear that FDA would classify the enhancements as a recall. To help resolve the situation, FDA prepared a draft guidance document.
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Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This webinar provides the tools needed to understand and implement acceptance sampling. It explains the basis for sampling plans, the binomial distribution, and uses it to understand the sampling plan’s performance using the operating characteristic (OC) curve.
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Excel Spreadsheets and FDA Device Regulations
This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets are automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them.
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