Two-Day Seminar: Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices (Los Angeles, CA, United States - November 17-18, 2016) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices" conference to their offering.

Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2-day seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company.

Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And design problems can have disastrous results for your customer and for your company.

In this seminar, we will cover Design Controls for medical devices. We will understand the requirements for design controls and how to translate them into an efficient and effective process for your company. We'll cover the history and requirements for design controls. Then we'll discuss requirements and tools in detail and include exercises to help you practice and improve your design control process.

Why should you attend:

Poor design of medical devices accounts for a significant number of recalls. Design issues can result in complaints and medical device reports. Design issues can even create issues with manufacturability for your company including low yields and excessive scrap and rework. Finding and fixing issues early on in design provide much more leverage than trying to fix problems for products already in production. This webinar can help you learn from past issues and improve your next generations of product.

Agenda

Day One:

Lecture 1:

- Overview and Expectations

Lecture 2:

- Design Planning

- Design Inputs

Lecture 3:

- Design Outputs

Lecture 4:

- Design Verification and Validation

Day Two:

Lecture 1:

- Design Review

Lecture 2:

- Design Transfer and Design Changes

Lecture 3:

- Design History File

- Linkages to Other Quality Sub-systems

- Inspection Preparedness

Lecture 4:

- Myths

- Challenges

- Best Practices

For more information about this conference visit http://www.researchandmarkets.com/research/75k9bs/design_controls

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices