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What's New in April 2021

Since compliance and risk management are complex topics, we decided to brighten up your day with some light reading recommendation on the topic. In this newsletter, we share our book review on Steve Casner's "Risk" with you that highlights how you can think about and avoid taking risks that lead to preventable injuries.

We released a new version of the SoftComply Risk Manager Cloud last week and in this Newsletter we will tell you about the improvements we have made.

You can also check out our knowledgebase articles on the SoftComply Risk Manager customization and automation.

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Risk Management is not what you would typically call an exciting activity. It is a slow and methodical process, based on data, science and educated assumptions.

This book is instead a light read. It does not cover medical device risk analysis, nor risk analysis at all as a structured process. It spaces instead through several industries, scenarios, including the most dangerous place you can step in: your own home.

It may not help you create a better risk management plan or give you an eye opening view on the device you’re currently working on, but it is full of small pieces on information that can provide interesting food for thoughts, especially from the user behavior standpoint.

Risk is about why we behave in such contradictory ways. It may also help us keep our fingers attached in the kitchen, our children afloat at the pool and teenagers safe behind the wheel. Casner shows us how and when injuries happen and in Risk we learn what we should really be worrying about.

Some examples below...

For the full book review with all the examples please continue here.

Multitasking

Apparently there is no such thing as “multitasking”. This is because multitasking is essentially switching your attention quickly between two things. And when you switch tasks, it takes at least 10 seconds for your brain to readjust.

When you are using your phone in your car while stopping at a red light, you will still be distracted 10 seconds after you have put the phone down. David Strayer has studied switching attention between driving and interacting with electronic devices and he claims that it takes drivers 20 seconds to fully recover from a behind-a-wheel distraction. In this time of attention hangover something quite dramatic may happen in traffic where you may be putting yourself and others in danger.

For the full book review, please continue here.

Patient’s noncompliance & cyberchondria

We want to be in full control about everything in our lives including our health. Even though we go to a doctor for checkups or when something is hurting or broken, how often have you decided to carry out an alternative recovery plan from the one your doctor suggested? You are not alone.

People are reportedly skipping prescribed medications and not taking their doctors advice. The real place where over 70% of people now go for their medical information is the internet. Sadly, most of these people quickly become cyberchondriac – where shopping for possible illnesses will get common symptoms linked to very serious and rare conditions.

Casner suggests we use the internet to supercharge our interactions with our doctors instead of diagnosing and treating ourselves.

Read more about this and other examples of preventable injuries here.

Getting older – cognitive and physical decline

We all know how life expectancy has steadily increased over the past hundred years. But on the topic of age and safety we are still relatively uninformed and ill-informed. Or simply in denial once we reach a certain age.

It is not that we do not see our physical and cognitive decline as we age, it is knowing when we are approaching the limits of our own safety as well as the safety of people around us. How many of us know when it is the time to hand over our car keys and be done with driving?

Casner discussed this with Meuser who admits that age is a weak predictor of functional capacity of whether or not it is safe to drive but who suggests simple tests to see if you should still be behind the wheel. Continue reading about the tests that you can take to determine if you (or your family members) should still be driving here.

Casner concludes that we need to pay a new, special kind of attention to looking out for ourselves and for others around us in order to make everyone’s life a little more safe from preventable injuries. Thinking ahead and planning for safety in advance takes patience and practice!

Be Safe Out There!

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Two new column types can now be added to the Risk Table of the SoftComply Risk Manager Cloud:

Remote link column type supports visualization of any existing external websites, including Confluence pages, to your risks in the risk table view. You will be able to add the remote link in the Jira issue view with the full url and the page name, which is visualized in the risk table.

Custom field column type supports mapping any new risk table columns to the already existing custom fields you may have in your Jira Cloud. This will enable reusing the existing fields you have already created. NB! Should you already have a specific field in your Jira that you want to display in the risk table, be sure to reuse that custom field by creating a custom field type column in the risk table and selecting the existing field. This way you will have avoided creating a duplicant custom field into your system. As such, you can create columns of epic link, number, Jira component field or any other Jira field type that already exists in your system.

For the entire list of different column types that you can add to the Risk Table, please see here.

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There are numerous articles in the SoftComply Knowledge-base including:

▪ How-To benefit from the SoftComply Risk Manager features and customization options,
▪ Frequently Asked Questions on why the Risk Manager works the way it does and how you can change various settings,
▪ Additional Tips & Tricks for adding automation on top of the SoftComply Risk Manager features.
How-To benefit from the SoftComply Risk Manager features and customization options,
Frequently Asked Questions on why the Risk Manager works the way it does and how you can change various settings,
Additional Tips & Tricks for adding automation on top of the SoftComply Risk Manager features.
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Join our webinars and training courses to learn more about:

* Medical Device Regulations & implementing a compliant Quality Management System - Register here,

* Medical Device Risk Management in Jira - Register here,

* Establishing Risk Traceability in Jira and Confluence - Register here.

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In case you cannot join the webinars, feel free to check out the webinar recordings in our YouTube channel about:

▪ Medical Device Regulations & the FDA compliant QMS Solution in Confluence,
▪ Risk Management in Jira with the SoftComply Risk Manager app, and
▪ Establishing Risk Traceability in Jira and Confluence.
Medical Device Regulations & the FDA compliant QMS Solution in Confluence,
Risk Management in Jira with the SoftComply Risk Manager app, and
Establishing Risk Traceability in Jira and Confluence.
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Check out & join our brand new Atlassian Jira online training courses!

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Benefits of the SoftComply Risk Manager PLUS for Jira Server:

▪ Supports Hazard Analysis and FMEA
▪ Supports FMEA with Detectability
▪ Displays risks in Matrices & RPN
▪ Supports FDA approval and CE-marking process
▪ Targeted towards safety critical domain users
Supports Hazard Analysis and FMEA
Supports FMEA with Detectability
Displays risks in Matrices & RPN
Supports FDA approval and CE-marking process
Targeted towards safety critical domain users

For full list of features of SoftComply Risk Manager PLUS, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

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Benefits of the SoftComply eQMS:

▪ Full Quality Management System for medical device co-s
▪ On ISO13485, IEC62304, ISO14971, FDA 21CFR 820
▪ Fully customizable with embedded guidance
▪ Reduces the cost of compliance
▪ Most competitive price
Full Quality Management System for medical device co-s
On ISO13485, IEC62304, ISO14971, FDA 21CFR 820
Fully customizable with embedded guidance
Reduces the cost of compliance
Most competitive price

SoftComply eQMS on Confluence Cloud:

The new MDR states that Quality System documents need to be searchable. You can now implement a compliant Quality System documentation on your Confluence Cloud! Access the free trial version directly from the Atlassian Marketplace and/or contact us to get a demo & discussion about the content of the product.

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Benefits of the SoftComply Risk Manager:

▪ Supports any software system/product risk management
▪ For both Jira Server & Cloud users
▪ Fully customizable for any type of risk project
▪ Automated traceability
▪ Support software system/product risk management
▪ Most competitive price
Supports any software system/product risk management
For both Jira Server & Cloud users
Fully customizable for any type of risk project
Automated traceability
Support software system/product risk management
Most competitive price

For full list of features of SoftComply Risk Manager, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

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