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Greenlight Guru and SIGMA SYSTEMS have the same goal and mission: to improve the quality of life by helping med device companies and manufacturers get to market faster with less risk. The problem? Many of the new startup companies find it difficult to respond to strict rules and regulations that are imposed to the world-wide medical device market. On the other hand, big companies are facing the issues of adapting to new regulations and fast implementation of changes that the market and regulation dictates.
Greenlight Guru created the only MedTech Lifecycle Excellence (MLE) platform in the industry, focused on quality, regulatory, and product development. With Greenlight Guru, there is a single source of truth accessible by both product and quality teams that streamlines collaboration and compliance, without stifling product development efforts.
On the same mission, SIGMA SYSTEMS provides support in preparing technical documentation according to market regulations, maintaining the effectivity of existing QMS system, performing management reviews, internal audits and preparing the company for successful external audit and putting the medical product on the market.
Both Greenlight Guru and SIGMA SYSTEMS are disrupting an industry to provide software tools and consulting services built specifically for the medical device industry.
The partnership presents medical device companies with industry-specific out-of-the-box software solutions in order to automate quality, regulatory, product development, and years of support.
