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We are happy to introduce the brand new features of our risk management apps (both SoftComply Risk Manager and SoftComply Risk Manager Plus) for Jira Server users!

Please update your app to benefit from the following features.

USER-ENABLED SORTING OF DATA IN RISK MANAGEMENT TABLE!

Data in the risk management table has so far been automatically sorted – the sorting algorithm starts from the left most column in the table and sorts it alphabetically. Next, each column from left to right is sorted alphabetically. This provides an easy to read structure to the table.

After several requests from our clients to allow users sort the table by one column of their own liking, we are happy to let you know that we have implemented this feature now.

Users can now disable the automatic sorting to sort the data by a column of their own choosing instead. User-enabled sorting is a project specific feature, i.e. user will have to enable it in each risk project.

Read more about how to switch to user-enabled data sorting!

CUSTOM COLUMN TYPES FOR YOUR RISK MANAGEMENT TABLE!

So far the only type of columns that users could add to the risk management table were text columns. After a few requests from you, we have implemented the following types of columns that you could add to the risk table:

Text area, Numbers, Date, Select, Multi Select, User, Version and Custom Field.

Read more about the custom columns you can now add to the Risk Management table!

SoftComply Risk Manager Cloud version will have these new features by the end of April.

For more information, please contact us.

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We are happy to inform you that the SoftComply Risk Manager Plus users can now also purchase Validation Package for regulatory compliance.

The validation package consists of the following documents (both templates and executed files): Validation Assessment, User Requirements Specs, Validation Plan, Test Protocol and Test Results.

You can easily repeat the validation protocol in-house to confirm the results of the pre-validation provided by SoftComply.

To read more about the requirement of validating your software tools, please see our previous blog post.

For more information on the Validation Package, please contact us.

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You can download a free e-book on MDR to find out:

▪ What is the MDR?
▪ Does the MDR affect you?
▪ How can you make your app MDR-compliant?
▪ How soon will you need to think about this?
▪ What are the implications for using cloud?
What is the MDR?
Does the MDR affect you?
How can you make your app MDR-compliant?
How soon will you need to think about this?
What are the implications for using cloud?
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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.

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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
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Join us in Edinburgh for EuroAsiaSPI Conference in September 2019!

You are welcome to describe your experiences and challenges in the medtech industry as a short paper and participate in the workshop on Safety & Security of Medical Devices.

 
     
 
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