Medical Device R&D Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.

This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.

This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.

This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.

This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.

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 process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.

This device compliance training will offer a basic understanding of the records required to fulfill requirements of both US FDA 21 CFR 820 and ISO 13485:2016 for establishment and maintenance of a Design History File (DHF). It will also help attendees understand what document control means for DHF records.

This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.

This training program will address when to exclude outlying data points from an analysis. It will illustrate how best to apply sensitivity analysis to determine the impact of removing data. Participants will learn to perform and interpret hypothesis tests for outlier detection.

This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.

This training program will provide an understanding of key areas of design focus for medical wearables. Attendees will learn best practices to implement product development plan that apply to medical devices.

This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.

This webinar will overview each critical aspect of the FDA submissions process to include 510(k) and PMA) and contrast those key steps to those of the EU Medical Device Directives Submissions process.

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.

This training program will highlight key metrics needed to convince reimbursement panels of design compliance and discuss how best to implement practices in your development process that ensure acceptance by reimbursement groups.

This course will provide a foundation for developing your technical skills related to sterility assurance.

This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.