As part of ResearchAndMarkets.com's training offering, the "Medical Device Design Control Essentials Course" training has been added to the site.
You can learn essential knowledge and establish robust processes for Design Controls in the production of safe, effective medical devices by participating in our immersive 2-day virtual seminar. As a crucial part of ensuring compliance and quality in the medical device industry, Design Controls are recognized by the FDA as a crucial process.
In spite of the importance of Design Controls, they are often overlooked, leading to frequent observations of 483s and Warning Letters. In this seminar, we are going to show you how you can integrate Design Controls effectively into your product development process, and ensure that the development process is not only streamlined, but also ensures the highest level of quality and compliance.
The seminar is designed exclusively for medical device designers, providing a thorough understanding of the essential requirements and how to translate them into processes that are tailored to meet the specific requirements of your company. In this course, you will learn about the history, context, and requirements of design controls, along with the detailed tools and techniques that go along with those requirements.
Take part in practical exercises that will enhance your skills and refine your design control process during this workshop. Don't miss this chance to stay ahead in the medical device industry by mastering the art of design controls during this workshop. 
WHAT YOU SHOULD ATTEND:The key to ensuring the intrinsic quality, safety, and effectiveness of medical devices is to begin with a robust design process. It is important to note, however, that alarming statistics indicate that the majority of medical device recalls are the result of design issues, which can be disastrous both for the customers and for the companies involved.
In order to prevent such quality and compliance issues from occurring, it is important to implement a rigorous and efficient design control process. By identifying and addressing issues at the onset, you will be able to resolve them faster and prevent costly setbacks from occurring. We invite you to attend our seminar to gain valuable insights and strategies that can help you avoid design problems and their negative effects on quality, cost, speed to market, and customer satisfaction..There is no doubt that Design Control is one of the most important areas that the FDA examines during its inspections of medical device manufacturers. Customer complaints and medical device reports can be triggered by design-related issues, and manufacturability issues, such as low yields, excessive scrap, and the need to rework parts, can also be triggered by these issues.
Customer complaints and medical device reports can be triggered by design-related issues, and manufacturability issues, such as low yields, excessive scrap, and the need to rework parts, can also be triggered by these issues.
When these issues are addressed and rectified early in the design phase, there is a much greater chance that they will be resolved successfully than if they are addressed after the product has already been produced.. This webinar will provide you with a chance to learn from past issues, thereby enabling you to enhance the quality and performance of your future product generations based on the learnings of the past.The goal of this virtual seminar is to provide students with an understanding of the regulations, the context, and the history of design controls.. As part of this course, students will learn how to use design control as a tool to ensure product quality while meeting the needs of the business for speed to market at the same time
As part of this course, students will learn how to use design control as a tool to ensure product quality while meeting the needs of the business for speed to market at the same time
In this course, students will gain a firm understanding of key concepts, practice in using these concepts, as well as extensive course notes for future use and reference:
Attendees should be the following:
SESSION 1 (10 AM to 3 PM) DAY ONE:
In the second session, we will discuss:
In the third session, we will discuss:
On the second day (10 AM to 3 PM) the first session will be held as follows:
In session two, we will discuss the following:
In the third session, we will discuss:
There is no doubt that Susanne Manz is an accomplished leader in the medical device industry who has a strong focus on quality, compliance, and six sigma. From new product development, to operations, to post-market activities, she has an extensive background in quality and compliance for medical devices. She earned a BS in Biomedical Engineering and an MBA from the University of New Mexico. While working at Johnson and Johnson, she earned certification in both Black Belting and Master Black Belting.
Additionally, Susananne holds the RAPS Regulatory Affairs Certification (RAC) and the American Society for Quality Certified Quality Auditor (CQA) certifications. In order to help medical device companies achieve world-class quality and compliance, Susanne has established a consulting company that provides services to help them achieve that. To find out more about this training, visit https://www.researchandmarkets.com/r/tg04x7.

Source prnewswire