Webinar 1: 7 essential elements of a risk management plan

LTR's monthly webinar series kicks off with a deep dive into risk management plans

Dear colleagues, hello! 👋

I am super excited to launch a monthly webinar series to help you gain a deeper understanding and build practical skills in risk management. This is an excellent way for you to engage with me 1:1 each month, ask questions and share your own experience.

First, a couple of housekeeping notes

This monthly webinar series is a premium feature available for free only to the paid subscribers. If you would like to gain access to the monthly webinar series and other premium features, consider becoming a paid subscriber. You can learn about subscription plans and benefits here.

If not, you can still attend this webinar by making a one-time payment of only $25. You will receive a zoom link for the webinar in a separate email.

Finally, this month’s webinar is scheduled for August 23, 2023 at 11:00 AM EST.

Now, let’s talk about what we will cover in this webinar

A risk management plan (RMP) is a key requirement of ISO 14971, the international standard for application of risk management to medical devices.

Good planning is essential to the success of any project and risk management is no different. A risk management plan helps you to apply an organized and systematic approach to risk management activities. It ensures that nothing is missed, and all outputs are delivered in an efficient manner.

In this webinar, we will review 7 essential elements of a risk management plan according to ISO 14971 requirements:

1. Scope of planned activities

2. Responsibilities and authorities

3. Review of activities

4. Criteria for risk acceptability

5. Method and criteria for evaluating overall residual risk

6. Verification activities (implementation + effectiveness)

7. Production and post-production activities

We will not only review these requirements, but also share best practices for effective implementation. As an example, we will talk about an optional 8th element to help you manage the lifecycle aspects of the risk management plan.

We will have plenty of time to discuss your specific questions and practical challenges.

Finally, you will receive a RMP template after the webinar.

What qualifies me to do this and why this webinar is worth the money

(Yes, these are important questions!)

• I have practiced risk management in the medical device industry for more than 10 years. Not only do I have a deep understanding of the requirements, but I also understand practical challenges in implementing these requirements.

• I have helped many clients to successfully address risk management questions from notified body auditors, and remediate their risk management files.

• I have helped clients to build a highly efficient and fully compliant risk management system from scratch.

• I have trained and coached many industry professionals. Check out what they have to say about their experience in these testimonials:

Try before you buy

Check out this free on-demand webinar on Hazard Analysis:

Take your risk management expertise to the next level

After attending this live webinar:

1. You will have a solid understanding of the 7 essential elements of a risk management plan per the requirements of ISO 14971;

2. You will learn how to effectively manage lifecycle changes in the post-market phase with an optional 8th element based on my years of industry practice;

3. You will have actionable suggestions to overcome some of your specific practical challenges in risk management;

4. You will have access to the webinar recording for a limited time; and

5. You will receive a free template for creating a risk management plan

If you are not a paid subscriber, you can attend this webinar for only $25

Click below to save your spot:

If you are a paid subscriber, you will receive a zoom link via email

If you are not yet a paid subscriber, upgrade today to gain free access to the monthly webinar series, including this webinar.