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Rapidly changing regulatory requirements

The regulatory environment is changing fast in the medical device industry. EU-MDR has heavy emphasis on risk management and many new requirements. FDA is working on harmonizing the Quality System Regulation with ISO 13485. It is difficult to keep up to find the right balance between compliance and practical execution. 

Burdensome and confusing documentation expectations

Due to changing regulatory requirements, auditors have much higher expectations for documentation in your risk management file. However, even within the same notified body, different auditors have different expectations. This is causing a lot of confusion in the industry and creating a lot of additional work. 

Limited expertise in risk management

In a recent survey, 43% of the respondents said that limited expertise in risk management is the most significant challenge in implementing an effective risk management process in their organization. In general, there is a lot of confusion in the industry about key terms and basic principles. As a result there are many mistakes during risk analysis and it is hard to explain during an audit.  

Lack of trusted sources of information and collaborative community

There are no trusted and reliable sources of information we can rely on for practical tips and guidance on risk management. There is no platform or community where practitioners can ask questions, share their own perspective and network with others. Available training options are very expensive and take up too much time. As a result, it is not easy to find quick answers to common practical challenges. 

Here is how ACHIEVE can help

At ACHIEVE, we are driven to help elevate our collective global capability in risk management across the medical device industry. By joining our newsletter you will have access to:

1. Practical tips you can use every day.
2. Upcoming events such as free webinars and podcasts you can attend. 
3. A large collection of free resources such as case studies and blog articles you can gain new insights from.
4. Special offers on world-class learning and personalized coaching opportunities you can benefit from.