LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability

LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability

From Let's Talk Risk! with Dr. Naveen Agarwal by Casual and informal conversations about practical aspects of medical device risk management.

May 1, 2026 · 29 min

About this episode

Naveen Agarwal speaks with Sherita Black about creating a policy for risk acceptability in medical device risk management.

Summary “Just having a policy in place is one thing. Having a QMS that aligns to it is the next.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Sherita Black about one of the most challenging and often misunderstood topics in ISO 14971: creating a policy for risk acceptability. The conversation goes beyond the standard’s wording and gets into the practical questions that many teams struggle with: who top management really is, how to involve them, and how to turn policy into something that actually drives decisions. Sherita brings a strong cross-functional perspective shaped by years of experience in pharmaceutical validation, medical device design quality, complaint handling, and enterprise risk management. In her current role as Risk Management Business Process Owner at BD, she focuses on maintaining risk management procedures, aligning stakeholders, and supporting an effective risk management program across the organization. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 – Introduction 02:48 – What ISO 14971 expects from top management 03:54 – Why a risk management policy matters 05:56 – Three…

People in this episode

Host: Naveen Agarwal

Guest: Sherita Black

Topics covered

  • risk management
  • ISO 14971
  • policy development
  • top management
  • medical devices
  • quality management system

Keywords

  • risk acceptability
  • policy
  • QMS
  • top management
  • risk control
  • auditors
  • competitive advantage

Mentioned in this episode

Organizations: BD

Books & works: ISO 14971

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