£300

Medical Device Risk Management Masterclass – Essential steps of MDR/IVDR

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Eliminate uncertainty in building compliant risk management files by attending our one-day masterclass in risk management in medical devices

About this Event

**Please note this is an online event **

Medical device malfunctions and design flaws lead to thousands of patient deaths every year. Risk Management is a key legal requirement in the regulatory approval process for medical devices, including software only systems. The new EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) include new requirements for Risk Management and the 2019 revision of the international standard for Risk Management, ISO 14971, has just been published.

Manufacturers can also expect greater Notified Body scrutiny in this area during MDR/IVDR Technical File assessments.

In our experience, risk management is typically not well understood and is frequently not implemented in a fully compliant manner. The consequences of failing to implement Risk Management include patient harms, product recalls and rejected regulatory submissions. Eliminate uncertainty in building compliant risk management files by attending our one-day masterclass in risk management for medical devices and In Vitro diagnostics - you will also receive the template documents to take away with you at the end of the session.

What you will learn:

• Why risk management is required

• Regulatory requirements

• ISO14971:2019, The ‘EU specific’ annexes and how to reduce risk ‘as far as possible’ in practice

• How to implement a pragmatic and effective risk management process

• Risk Management Planning

• Risk Analysis including tools such as Fault Tree Analysis (FTA) and Failure Modes and Effects Analysis (FMEA)

• The right way to assess risk with defensible assignment of probability and severity values

• Information security as a risk and how to control it

• Risk Evaluation and how to create Risk Acceptability Criteria

• Risk Control and how to build safe systems by applying state-of-the-art Functional Safety techniques

• Information security and cybersecurity threats

• Residual Risk Analysis

• How to perform a Risk Benefit Analysis – quantification of both risk and clinical benefit

• How to integrate the Clinical Evaluation Report (CER)

• The Risk Management Report

Attendees will also receive the following template documents:

• Criteria for Risk Acceptability

• Risk Management Plan

• Hazard Analysis

• Failure Modes and Effects Analysis

• System Level Risk Traceability Matrix

• Software Risk Analysis

• Risk Management Report

This training session is lead by UOVO's CEO Peter Brady, a med-tech specialist with deep understanding of business and technology in the digital health and medical device sectors. He has thirty years’ experience of the industry, including as director with a leading medical device manufacturer and managing consultant with renowned technology consultancies. He is an award-winning leader in innovation and product development working on strategic direction and technology management. With his broad range of knowledge and experience, Peter is the ideally qualified to guide you through this often poorly understood, but essential regulatory approval process.

You will leave this session with the knowledge you need to bring a safe and compliant medical device to the market that is fit for its intended use.

**Group Discounts are available for 4 or more attendees in a single booking. Please contact info@uovo-technologies.com for more information.**

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Eventbrite's fee is nonrefundable.

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