Edwin Waldbusser
Edwin Waldbusser
Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.
Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
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Medical Device Hazard Analysis following ISO 14971
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented. FDA recommends using ISO 14971 as a guide and... -
FDA Regulation of Artificial Intelligence / Machine Learning
AI / ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance’s for years, however, AI/ML programs fall outside the scope of these regulations... -
How to Prepare for and Host a FDA Inspection and Respond to 483’s
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock... -
Handling Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be discussed.... -
FDA Regulation of Artificial Intelligence / Machine Learning
AI / ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance’s for years, however, AI/ML programs fall outside the scope of these regulations... -
Conducting an Effective Software Validation of Medical Device to Meet FDA Requirements
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will... -
FDA Regulated Mobile Medical Apps as Devices and Cybersecurity Explained
This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA cybersecurity requirements. The FDA approval process for mobile apps will be explained including FDA software validation requirements... -
21 CFR Part 11 Compliance for Electronic Records and Signatures
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11.... -
4-Hour Virtual Seminar on Design Control Program with Detailed Hazard Analysis, Human Factors and Software Discussions
US FDA believes that a device cannot be considered safe and effective unless the design has followed a rigorously controlled step by step process. This virtual seminar will teach you how to set up and maintain a process that... -
Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience
Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the Contract Manufacturing Organization (CMO). CMO’s must be selected following a rigorous... -
How to Prepare a 510(k) Submission
We will explain what a 510(k) is and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of predicate device and substantial... -
Medical Device Cybersecurity Following Latest FDA Guidance
Medical devices using the software are similar to other computer software and systems; they can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. It is essential that companies establish a program where they... -
Human Factors Usability Studies Following ISO 62366 and New FDA Guidance
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design...
