Ultimately risk is not a simple matter. There are many different connotations of risk. Medical device manufacturers need to understand the impact of risk mitigation strategy on everything from a regulatory submission to a risk management plan to design control.
This seminar will demonstrate important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities. All medical device pathways to market are presented with a discussion of the advantages and challenges of each.
In many ways, the de novo is the simplest pathway to market, even simpler than the 510(k). Furthermore, the de novo can provide a competitive advantage as a barrier to entry for your competition.
This course will teach you to develop a regulatory plan using existing pathways to create barriers that will make it difficult for your competition to follow in your footsteps. Additionally, you will learn how streamlining the process actually works in your competitive favor.
Through this course you will be able to assess your existing quality system processes and understand the changes that will need to be implemented in your organization to comply with the revised ISO 13485 standard and to meet expectations from notified bodies.
This course will be of benefit to anyone in the life sciences who is interested in 3-D printing as a method for developing a therapeutic product (e.g., medical device, drug delivery system, etc.), including those already using 3-D printing but want a better understanding of FDA’s position on the subject.
In this training, you’ll learn the five common areas where device trials tend to fail, plus review actionable steps to help you anticipate potential pitfalls and resolve them before they occur.
This course is designed to provide you with an understanding of the concerns of FDA investigators, the methodologies used by the FDA and the tools necessary to successfully manage these inspections.
