Medical Device Design Concepts

Design Control Compliance for FDA & ISO

(On-site or Virtual Private Group/Company Training)

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Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

Overview:
 
FDA investigators are inspecting and pursuing enforcement activities for non-compliant Design Control violations. FDA has published that 68% of firms inspected had potential design control non-compliance and 55% of Warning Letters cited Design Control violations. As one of the four major subsystems within FDA's QSIT inspection program, expect your Design Control System to be inspected. Warning letters published repeatedly cite Design Control deficiencies. Design Control is also a very important element of ISO 13485 in which non-compliance can result in the risk of losing your CE Marks and therefore the ability to market your devices internationally. This program discusses Design Control, the regulatory requirements (U.S. & International), and methods for implementing and maintaining a successful Design Control process. A poorly implemented Design Control process can add delays and frustration to R&D teams while an efficient Design Control system will allow teams & companies to be remain creative, meet schedules, and stay compliant. Design Control Flowcharts will be provided to assist with modeling of Design Control procedures and the implementation of an efficient Design Control program. This course is applicable to R&D and RA/QA personnel who are responsible for their company's Design Control program. It is very beneficial for R&D engineers, QA engineers, RA, Management, Marketing, and Manufacturing personnel who participate in the design control process or may be members of a design team.

What you will learn:

Benefits of Attending:

Abbreviated Outline:

Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.

Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.

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