Jun 4, 2018
Qt Partners with Emergo to Accelerate Time-to-Market for Medical Devices
Qt’s user-friendly and efficient software development framework combines with Emergo’s global regulatory expertise to streamline medical device manufacturers’ path to market.
ESPOO, FINLAND and SANTA CLARA, CA (June 4, 2018) – Today, Qt (HEX: QTCOM) announced a new partnership with Emergo, a global medical device regulatory consulting firm, to help Qt’s medical device manufacturer customers accelerate time-to-market for their products. The partnership will leverage Emergo’s expertise in global medical device regulations, along with Qt’s highly efficient software development framework, to enable Qt’s customers to navigate regulatory approvals so they can enter new markets faster and more cost effectively than ever before.
The medical industry has a wide range of regulations and processes in place to ensure that doctors, nurses, and patients have access to medical devices only after the device is proven to be both safe and effective. As a result, bringing a product to market takes a significant amount of time, money and resources, with the average time-to-market for a medical device falling between three to seven years. Understandably, medical device manufacturers are eager to reduce that time window so they can realize a return on investment as quickly as possible and make their state-of-the art technologies available to the industry.
Qt takes a three-pronged approach to helping its customers navigate medical device industry regulations, consisting of
1) certification of Qt’s own products
2) full transparency into Qt’s development process, product performance, and internal validation and testing and
3) access to an experienced and diverse partner ecosystem.
Through the new Emergo partnership, Qt is able to fully support its customers’ regulatory and compliance efforts in order to gain market clearance, including compliance with regulations and standards set by the FDA, EU, ISO and IEC. As a result, Qt’s medical device customers can align their product development cycle with global regulatory process requirements, making their overall time-to-market process faster and more efficient.
“While Qt, through its software development framework, enables companies to speed up the process of device development, getting past the regulatory hurdles in countries worldwide is still a challenge and can delay the entry to a specific market,” said Dr. Benjamin Grosse-Siestrup, PhD, Business Development Manager for Emergo. “By partnering with Emergo, Qt is providing a more complete service offering to its customers along the entire product lifecycle, which includes international medical device and IVD market clearances.”
According to a recent survey, more than 84 percent of Qt’s customers report that they are more productive with Qt, and highlight that productivity of projects has as much as doubled through their usage of Qt.
“We understand how challenging it is to develop innovative medical devices, and we realize that providing a comprehensive software development framework solves only part of the challenge of getting medical devices to market faster,” said Roger Mazzella, Senior Product Manager for The Qt Company. “The other part of the challenge is clearing the medical device in markets all over the world. As a result, our goal is to support our customers through the entire innovation and product launch cycle, which includes helping them navigate the critical step of global regulatory market clearance. With our partnership with Emergo, we’re providing our customers with the resources they need get their groundbreaking products to market faster than ever before.”
In addition to this new partnership, last month Qt introduced the Qt Safe Renderer tool to integrate functional safety compliance into the software development process for safety-critical systems and devices. Qt Safe Renderer is certified by TÜV NORD according to functional safety standards for the automotive, medical device, industrial automation, railway and other safety-critical industries.
Learn how Qt can support your regulatory and compliance efforts: https://www.qt.io/qt-in-medical/
For more information regarding Qt’s attendance at upcoming medical device-focused events, please visit Qt’s events page: https://resources.qt.io/upcoming-events-tradeshows-seminars-conferences
Founded in 1997 to help US medical device companies obtain CE Marking and export their products to Europe, Emergo has since grown into a leading consultancy supporting more than 2,800 medical device and IVD clients worldwide. With offices in 25 countries, Emergo provides compliance services including regulatory strategy, device registration, quality management system compliance and in-country regulatory representation. For more information, visit EmergobyUL.com.
About Qt Group
Qt Group Plc (Nasdaq Helsinki: QTCOM) is a global software company with a strong presence in more than 70 industries, and is the leading independent technology behind millions of devices and applications. Qt is used by major global companies and developers worldwide, and enables its customers to deliver exceptional user experiences and advance their digital transformation initiatives. The company's net sales in year 2017 totaled 36,3 MEUR and it employs over 250 people. To learn more, visit http://qt.io.
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