Knowledge Base

14 Nov 2017 Risk Management for Health IT Systems

Although most, if not all, of the IT systems used in Hospitals do not fall into the category of medical devices themselves there are a lot of similarities between the two. Many hospitals in the US are already undergoing extensive IT expansion, so than most of the medical devices can be linked to the main […]

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19 Oct 2017 Medical Device Regulations and Software

Software in the Medical Device Regulations World   A lot has already been said regarding the new classification of software under the Medical Device Regulations. Scaremongering and rumours are already running wild, as if any Step Counter app would now be on the same level as the firmware of an implantable pacemaker. Let’s try to […]

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22 Sep 2017 Risk Management for JIRA. Why?

Compliant Risk Management is a mandatory regulatory requirement for companies in medical device and other safety-critical domains. It is a specific aspect of safety-critical system development that requires linking risks to system/software design and testing to ensure the system is safe to use. Various standalone solutions exist today for safety-critical system developers that help automate […]

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18 Sep 2017 How to Customize your Product Risk Matrix in Atlassian Jira

With SoftComply Risk Manager , you will work with a fully customizable Risk Matrix to identify, evaluate, mitigate and verify your product risks. SoftComply Risk Manager automatically generates Risk Matrices and Risk Reports! SoftComply Risk Manager is an add-on for Atlassian Jira – try it out for free for a month from Atlassian Marketplace.

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29 Jun 2017 FME(C)A or FMEA?

FMEA or FMECA? Criticality or not? Which one is better? Which one should you use? The answer is simple: it depends. You are probably fed up with the “it depends” answers you get in this sector. But in this case it means “It depends on YOU”. First the compliance bit: there is no requirement, in […]

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21 Jun 2017 FDA, Compliance and the Cloud

Cloud based tools have a lot of appeal for small companies and startups: no need for IT infrastructures, servers, IT management, recovery plans, backups and so forth. The use of cloud tools has always been a bit of a challenge in regulated environments, where the lack of control over the tools seemed to be a […]

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8 Jun 2017 4 Challenges of Safety Critical Software Development

When someone’s life is in your hands, you are going to be very careful with it. That’s why the safety-critical software used in aviation systems, automotive, traffic signals, or medical devices has always relied on highly-structured software development methods like waterfall. With a heavy emphasis on design review and testing, these methods are naturally quite […]

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18 May 2017 Afraid of the new MDRs?

By Matteo Gubellini, Chief Regulatory Officer at SoftComply Who’s afraid of the MDRs and the new approach to risk management in the EU? Well, everyone! The new and scary regulations for medical devices in the European Union will be made effective towards the end of this month. Driven by the necessity of updating an old […]

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12 May 2017 What is a Risk/Benefit Analysis & How To Do It?

The Risk / Benefit analysis is one of the most misinterpreted areas of the Risk Management process. And consequently one of the preferred digging points for the Notified Bodies. The spirit of the regulations and standards is “the benefit provided by the use of the device must outweigh the associated risk”. That sounds simple doesn’t […]

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2 May 2017 Risk Management – part of a Quality Management System?

Risk Management is a key and mandatory part of a medical device development process. Unfortunately, Risk Management is often treated as merely an exercise required to achieve compliance rather than a tool to achieve an optimum design and to ensure the safety of the medical device. Let’s see how to get the best out of […]

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30 Mar 2017 What is FMEA and how is it different from Hazard Analysis?

From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an inductive technique using the question “What happens if … ?”. Components are analysed one at a time, thus generally looking at a single-fault condition. This is done in a “bottom-up” mode, […]

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20 Mar 2017 Automated vs Paper-Based Document Control

Although this process can be extremely complicated and interlaced in large corporations, the requirements for Document Control are actually quite simple. Let’s give a look at them: ISO 13485:2016 – it’s all in two paragraphs, §4.2.4 and §4.2.5: (a) Documents must be approved, i.e. have signatures (electronic or handwritten); (b) If reviewed or modified, they […]

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15 Mar 2017 New Medical Devices Regulation & Risk Management

The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one. Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate. MDR highlights the importance of medical device risk management. Although risk management has […]

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13 Mar 2017 What is FMEA and when to use RPN?

Per ISO 14971, “Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis (FMECA) are techniques by which an effect or consequences of individual components are systematically identified and is more appropriate as the design matures.” We won’t go into the details of the FMEA, but often we were asked to explain when (and […]

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14 Feb 2017 SoftComply Risk Manager for Atlassian JIRA Cloud users now available!

SoftComply is pleased to announce that the first add-on for product risk management for JIRA Cloud users has arrived. SoftComply Risk Manager is a fully customizable risk management tool allowing users to identify, manage, mitigate, verify, trace and report product risks. Developed specifically for the needs of safety-critical product risk management, SoftComply Risk Manager provides […]

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1 Feb 2017 SoftComply eQMS for Medical Device Companies has arrived!

SoftComply is pleased to announce SoftComply eQMS, the first Atlassian add-on addressing the needs of life-science, medtech and pharma companies has arrived. SoftComply eQMS: • fast-tracks the implementation of a compliant Quality Management System for medical device companies; • is comprehensively focussed on the EU and US based markets, and helps users fulfil their requirements […]

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17 Jan 2017 How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA

Part II By Matteo Gubellini, VP of Regulatory Affairs at SoftComply* So you are looking for a Risk Management tool? Something easy to use, with good traceability features? There is plenty out in the market to pick from. All of them good tools, that tick all the boxes. I have been there several times, both […]

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9 Jan 2017 How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA

Part I By Matteo Gubellini, VP of Regulatory Affairs of SoftComply* “Ok, let’s follow a few of these risk mitigation actions down to outputs and verification activities” says the auditor. Typical question. Actually there couldn’t be a more typical audit question. Traceability. We have been here dozens of times. And every time it’s the same […]

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14 Dec 2016 A Fully Customizable Quality Management System for Your Medical Device Company!

Numerous companies struggle to enter medical device domain due to strict regulatory requirements for medical device products. Similarly, large medical device manufacturers have a difficult time finding suppliers that are not only innovative but also compliant with the regulatory requirements of medical device domain at the same time. A Quality Management System (QMS) is a […]

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8 Dec 2016 Struggling with risk traceability in your safety critical product designs?

Coming up: the SoftComply Risk Manager! In most safety-critical product development projects, the product has to receive external agency approval and/or pass an audit prior to release to market. One of the aims of such an approval is to check whether the product is safe to use. In order to demonstrate this, it is usually […]

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30 Nov 2016 Medical Device Software – it’s CLASSIFIED!

By Marion Lepmets, CEO of SoftComply* & Tom Stamp, CEO of Blue Curve** Following our article from last week on “Is My Software a Medical Device” to those of you who are now convinced that your software is indeed a duck (see the original article), then you are probably wondering “How do I get it […]

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23 Nov 2016 Is my Software a Medical Device?

By Marion Lepmets, CEO of SoftComply* & Tom Stamp, CEO of Blue Curve** If it looks like a duck, swims like a duck, and quacks like a duck, then it’s probably a duck… or a medical device! Medical devices can be purely hardware based (eg stethoscopes), be composed of hardware and software (eg patient monitor) […]

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16 Nov 2016 Cloud-Based SaaS Tools & Software Validation Compliant with Medical Device Regulations

The continued rise in the use of cloud-based and SaaS (software as a service) tools adds further challenges to the already complex domain of medical device software development that needs to adhere to regulations. How can medical device software developers and healthcare providers benefit from cloud computing while being compliant with regulations that require full control over the software […]

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9 Nov 2016 An Overview of Medical Device Software Regulations – International Standards and FDA Guidance Documents

Medical Device Software Safety Safety is the central concern for medical device software development. Development of safe systems is rigorously supported by various regulatory requirements focusing on development process compliance. In other words, a strong emphasis is placed on regulatory oversight and device approval before market release to ensure proper verification and validation of these […]

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21 Oct 2016 Similarities and Conflicts Between Agile and Safety-Critical Software Developers

In the last two weeks, SoftComply went to the Atlassian Summit and to the Advamed Conference. Both, the software conference and the medical device conference were huge in their number of attendees as well as in the number of parallel sessions with interesting talks and wonderful networking opportunities. Yet, it would be hard to find […]

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13 Oct 2016 Is Europe More Innovative Than the US?

  Europe has a more distributed approval system which has resulted in medical devices being approved and made available in Europe three to four years before these devices are approved in the US1. Even if Europe provides a faster route to market for medical device products, it has not affected their safety, i.e. there is […]

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5 Oct 2016 Building Medical Software Compliance on Atlassian Tools

What is Atlassian Summit? The biggest annual event of Atlassian will take place next week with hundreds of Atlassian users and developers descending to San Jose to listen to the success story of one of the fastest growing enterprise software technologies today. Their high-velocity distribution model drives an exceptional customer scale by making affordable products […]

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28 Sep 2016 Small, Innovative & Compliant: Innovation in Medical Device Domain comes from Small Companies!

A year ago, the panel of medical and academic experts at the US Policy Network’s annual meeting said that the fast-moving medical technology innovations are threatened by established interests and government regulations1 . The challenges of getting innovative medical device products out to market are subject to major regulatory audits that take a lot of […]

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22 Sep 2016 Building regulatory compliance into the software development life cycle

Safety is the central concern for medical device software development and the development of safe systems is rigorously supported by various regulatory requirements focusing on development process compliance. In other words, a strong emphasis is placed on regulatory oversight and device approval before market release to ensure proper verification and validation of these devices. Due […]

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19 Sep 2016 Software risk management in safety-critical domains

In the Medical Device market, safety is defined as freedom from unacceptable risk. Even regulatory agencies acknowledge that there is no such thing as a risk-free medical device. Medical device manufacturers have to aim for safer medical devices which, in turn, result in fewer device recalls. Risk Management is the process by which software risks […]

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19 Sep 2016 The worlds of software development and medical devices could not be further apart

Software development is agile, fast and innovative, while medical device development is often slow, reactive and change adverse. SoftComply has developed a set of tools which will help your company comply with the regulatory requirements with the minimum effort and get your innovative medical devices to market faster. Numerous software companies struggle to enter medical […]

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