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Modern medical device regulations are putting more and more emphasis on the management of software tools.

These tools are software packages that are not part of the medical devices themselves, but support the device during its lifecycle.

Nowadays companies use dozens of applications, ranging from accounting tools to email clients to software compilers. Of course not all of them have an impact on the product, so which ones should be validated and how?

The first step for any situation is to assess the software tool for its impact on the medical device. If it can have an impact on the “quality” of the device (in the broader sense), then validation may be required. Consider also that the software tools used to manage your Quality System, including CAPAs, complaints, NCs, requirements, risks, etc., fall into this category.

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SoftComply now provides a validation package for the the SoftComply Risk Manager Server version. Validation package for the SoftComply Risk Manager Plus will become available from February 2019. For more information, please contact us.

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Come and join us for a workshop on Medical Device Regulations and learn about the regulatory requirements you need to comply with when developing medical device software!
Speakers from Kasve OY (Finland) and from SoftComply (Estonia) will take you through the new Medical Device Regulations & software tools that support medical device and/or software developers in achieving this regulatory compliance.

Online Registration is now open.

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Introducing SoftComply's New Collaboration Partner Castor

SoftComply has established a closer collaboration with Castor to support our clients who need to run Clinical Studies.

Castor supports medical device companies in running their Clinical Studies. Have a look at how to get started with Clinical Studies in a blog post published by Castor.

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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
▪ Based 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
Based 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 submit research or workshop papers to the conference and participate in the thematic workshop on Safety & Security of Medical Devices, among others.

 
     
 
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