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 time and money for the manufacturers. With software being a medical device in its own right when it falls under the definition of a medical device2, 3, the medical device software developers have to adhere to the same regulatory requirements as large medical devices do. This means FDA approval for companies placing their products to market in the USA and CE mark for the EU. The path to approval is both time-consuming as well as costly with the average of 77% of a medical device budget required for regulatory compliance in the US4. With the majority of innovation stemming from small firms, the ability to maintain the competitive position and to produce technologies to address the needs of patients is put at risk5.
By the time that all the required standards are implemented in and regulatory audits are passed by a medical device company, the competition for innovative medical software products might already have increased and the window of opportunity might be closing quickly. It takes more than half a year to implement one standard alone on the path to compliance!
Software Risk Management: from manual filling of tables to interactive add-on in your software development environment!
According to a study among medical device companies by Pharma IQ, the regulatory compliance related considerations are the biggest challenge among the medical device companies today6. Besides the biggest spend on security and usability by the medical device companies, software risk management is the third largest segment to which the companies are investing in.
Software Risk Management ensures the safety of the medical device software and is therefore a part of the regulatory approval process prior to placing the products to market. Software Risk Management is a process for a manufacturer to identify the hazards associated with medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The biggest challenge for most software risk management tools is to combine it with the software development lifecycle so that risk management would, in fact, become a part of the software development process. SoftComply offers a solution for that by having developed an add-on for JIRA, SoftComply Risk Manager (more on SoftComply Risk Manager), that software developers on Atlassian can easily manage their risks with in the environment they develop their software.
SoftComply Risk Manager will help you manage your medical device software risks, link them to software requirements for risk control measures and to test cases for the verification of these measures. SoftComply Risk Manager also provides the automatic generation of the initial and residual risk matrices together with the Risk Management Plan and Report for regulatory audit purposes.
SoftComply Risk Manager follows the pricing model of JIRA with monthly licensing fees making it affordable to the small and innovative medical device software companies!
Quality Management System: from the folders on your shelves to your company’s collaboration software!
Streamlined and well defined standard operating procedures can do more than assist with remaining compliant to regulations now, they can help you adapt to the new regulations coming into place in the next few years7.
Quality Management System should describe an organization’s ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Quality Management System (QMS) is a living part of a medical device company and should be kept up-to-date. It should be central to all employees of the company that need to work according to the procedures & also tailor and describe project-specific processes. The best way to achieve this is to keep your QMS in the environment in which the employees communicate in.
SoftComply provides a solution for this by offering an electronic Quality Management System that is an add-on for Confluence that fast-tracks the creation of your company’s QMS with quality manual, quality policy, SOPs and templates that are required in the medical device domain.
SoftComly eQMS (have a look at the SoftComply eQMS) follows the pricing model of Confluence with annual licensing fees that allow continuous upgrades of the content when the underlying standards are being revised without you having to worry about the changes in the standards.