Quality assurance in medical device manufacturing takes a step forward through partnering of software provider Greenlight Guru with consulting firm Emergo. The two companies are combining efforts to create comprehensive quality management and regulatory affairs services, which can scale up globally. Their respective offerings are different but highly complementary in nature, a blend of both in-person consulting and software solutions that will serve their customers holistically.
On Greenlight Guru’s side, it will bring its leading medical device quality management platform software (MDQMS) to medical device maker customers. Emergo will dovetail in its cloud-based regulatory software management software (RAMS) and its consulting services that support companies with creating and maintaining quality systems.
“Legacy-based systems are all too common in the medical device industry; however, building a quality management system from scratch or phasing out an old system can be a daunting task,” said David DeRam, CEO of Greenlight Guru. “Our relationship with Emergo… seeks to streamline this process by pairing [our] purpose-built quality management system alongside… [Emergo’s] award-winning consulting services.”
The partnership is geared towards helping medical device manufacturers get their products to market faster. Customers will be able to simplify and automate their device design documentation and quality procedures to ensure they are in alignment with industry regulations and standards, including ISO, FDA, EU, and others. They will also be able to oversee their device registrations globally and check readiness for audits in real-time. When a personal touch is required, they will be able to access representatives from within a global network of countries or speak with QA/RA experts for insights on best practices.
As a provider of MDQMS, Greenlight Guru is helping its customers focus on quality – not just compliance. Just following the rules will only get companies so far, the firm says and urges them to lead with innovation. And while they are creating the next medical device miracle, these makers might need a system to help them manage their quality processes.
According to McKinsey, poor quality costs companies significant money. The organization found that the total cost of sub-par products ranges between 6.8 percent to 9.4 percent, which represents a $26 billion to $36 billion loss to the medical device industry. Changes to these crucial quality procedures can make a big difference to both the company and the industry.
Emergo Group is a consulting group founded in 1997 to help American medical device companies navigate the tricky waters of international regulatory guidelines for European markets. The firm quickly grew into one of the leading consulting firms with more than 2,500 medical device and IVD clients spanning the globe. Presently, the company operates offices in 25 countries and offers services for a broad range of compliance and market access initiatives.