Standards – Fact, Fiction or Fad?
This event will help you to learn what the value of standards are including how and when to engage in the development and use of the standards. You will hear some examples of best practices as well as Faux pas’s. You will learn about the various types of standards and what being involved brings you. You will hear about potential tools and the value of relationships and communications in the standards world. Areas Covered Value of Standards throughout the Total Product Life Cycle Challenges and potential ways to address the hurdles Overview of the Regulatory Environment and it’s Relationship with Standards Who Should AttendMedical Device: Business Leaders, R&D, Quality & Regulatory Leader. Why Should You Attend As regulations get more complex and technologies are changing at a rapid rate, it’s important to find ways to support all stakeholders to medical devices by getting your products to market quickly in a safe and effective manner. The stakeholders include OEM Technical Personnel, Clinicians (Users), Patients, and Regulators. Each of these roles brings their expertise to the table and if you don’t understand how and when to use a standard, you aren’t serving yourself and the other stakeholders.Topic BackgroundOpportunity to learn the perspective of a Medical Device Regulatory Expert on the importance of understanding the value of standards how to engage.
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This event will help you to learn what the value of standards are including how and when to engage in the development and use of the standards. You will hear some examples of best practices as well as Faux pas’s. You will learn about the various types of standards and what being involved brings you. You will hear about potential tools and the value of relationships and communications in the standards world.
Areas Covered
- Value of Standards throughout the Total Product Life Cycle
- Challenges and potential ways to address the hurdles
- Overview of the Regulatory Environment and it’s Relationship with Standards
Who Should Attend
Medical Device: Business Leaders, R&D, Quality & Regulatory Leader.
Why Should You Attend
As regulations get more complex and technologies are changing at a rapid rate, it’s important to find ways to support all stakeholders to medical devices by getting your products to market quickly in a safe and effective manner. The stakeholders include OEM Technical Personnel, Clinicians (Users), Patients, and Regulators. Each of these roles brings their expertise to the table and if you don’t understand how and when to use a standard, you aren’t serving yourself and the other stakeholders.
Topic Background
Opportunity to learn the perspective of a Medical Device Regulatory Expert on the importance of understanding the value of standards how to engage.