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If you cant beat them join them

"if you can't beat them, join them!"

If your company has decided to enter the medical device market, and you are in charge of making this transition, one of the things you will have to implement sooner or later is a compliant quality system.

The purpose of a medical device quality system is to ensure the product you develop is safe and effective. And this is what a manufacturer wants too, with the addition of making it a profitable business. How can the two things go together, when the regulatory requirements seem to add overhead everywhere?

To continue reading about how to use a Medical Device Quality System for your benefit, please read on from our most recent blog post.

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Need a compliant Quality System 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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Medical Device Workshop

at EuroAsiaSPI Conference on Sept 5-7

in Bilbao

Join us for talks & discussions on the new MDR, Medical Device Safety & Security, Risk Management and the FDA's Case for Quality. Registration now open!

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Benefits of the SoftComply Risk Manager:

▪ Fully customizable for any type of risk project
▪ Automated traceability
▪ Supports FDA approval and CE-marking process
▪ Most competitive price
Fully customizable for any type of risk project
Automated traceability
Supports FDA approval and CE-marking process
Most competitive price
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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
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
 
 
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