Medical Device Design Control: How to be in Sync with FDA’s Requirement

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Expert speaker Dr. David Lim will shed light on the FDA’s regulatory requirements for a medical device design control system in a 60-minute LIVE audio session at Don’t miss out on this opportunity!

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Quality management needs to be the top priority of every medical device company as it is essential for the core business processes that drive a company's productivity and growth.

In the medical device industry regulatory compliance is serious business. There is a lot at stake, from patient safety to company reputations, negative publicity to hefty fines in case of negligence. Quality management needs to be the top priority of every medical device company as it is essential to drive a company's productivity and growth.

Device manufacturers are required to establish and maintain FDA-compliant quality management systems to ensure that their products meet applicable requirements and specifications— including a design control subsystem. The Food and Drug Administration's (FDA) CFR 21 Part 820—“Quality System Regulations” are found in Section 820.30* and Section 820.40 **, and these two sections summarize the most vital aspects of medical device documentation for companies that comply with the regulation. However, these sections are not enough to either fully comprehend the impact of a company’s medical device quality system or the complexities of the regulations.

The huge number of medical device suppliers comes with an equal number of processes, procedures, and controls that are developed specifically for the medical devices being produced. It is imperative to comprehend the workings of the FDA and how it tries to regularize a specific business to the regulation when auditing that business for design control compliance. Understanding FDA’s POV will enable the manufacturers to have a smoother review of their design control system, leading to a successful audit of a company’s design processes.

President and Principal of Regulatory Doctor (, Dr. David Lim, would shed light on the regulatory requirements for a medical device design control system including design history file (DHF), device history record (DHR), and device master record (DMR) in a power-packed audio session “Demystifying Medical Device Design Control Requirements, DHF, DHR, and DMR” on Wednesday, October 15 at 1 PM ET. David will present practical and actionable guidance on how to effectively implement design control requirements as a subsystem of the quality management system.

Take a look at the topics covered in the session:

  •     Laws and Regulations
  •     Definitions
  •     Design and Development Planning
  •     Design Input and Output
  •     Design Review
  •     Insights on Design Verification And Validation including Software Validation
  •     Insights on design transfer
  •     Insights on design changes
  •     Overview of Design History File (DHF)
  •     Overview of Device History Record (DHR)
  •     Overview of Device Master Record (DMR)
  •     How to avoid the common pitfalls
  •     Enforcement Actions: Case Studies
  •     Learn from the PASS-IT Recommendations, and the Best Practices
  •     Q & A session

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Adam K
HealthAudio LLC
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Adam K
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