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IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment. Although if focuses primarily on electromechanical devices, it also applies to aspects of the software components. It is a widely recognized standard that most, if not all, medical device companies have to comply with.

The concept of Essential Performance of a Medical Device is at the center of IEC 60601-1. It is intended to be one of the outputs of the Risk Management Process.

Essential performance is defined as "performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable risk. NOTE: ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or degradation would result in an unacceptable RISK".

Essential performance is intended to be a risk-based approach, where failures resulting in unacceptable risks are pointers to essential performance.

But, as required by ISO 14971, unacceptable risk is by definition, well, not acceptable. The manufacturer must mitigate it to bring it to an acceptable level. So, after mitigation, all risk should be acceptable. Does it mean there is no Essential Performance?

To read on, please visit our blog post on IEC 60601, essential performance, safety and risk management.

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Agile in medical device domain and tools to support regulatory compliance

SoftComply will join our partner Pedco AG in Hall 9 at Stand 427 on May 22, 2019. We hope to see you there!

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HIMSS

Matchmaking at HIMSS Europe

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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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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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