Greenlight Guru announces True Quality Summit Series

Greenlight Guru, the leading medical device quality management software (MDQMS) platform, has announced the True Quality Summit Series: EU MDR and IVDR, a free, five-day online event to help quality, regulatory and product development professionals understand the new EU medical device regulations.

The True Quality Summit Series will take place March 22 through March 26, 2021.

The European Union (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) were created to promote patient safety, transparency, traceability and clinical evidence throughout the product life cycle in order to ensure product safety and efficacy.

The MDR establishes specific and preventive requirements to verify that products introduced to the EU market will not negatively impact the environment or patient health. However, medical device companies will face a heightened risk of noncompliance once the regulation goes into effect on 26 May, 2021.

Failure to comply with the new MDR requirements can negatively impact European manufacturers in many ways, including products being withdrawn from market.

Jon Speer, founder of Greenlight Guru, said: “Failure to comply with the updated EU MDR standards costs time and money, which can threaten the quality and speed to market of past, present and future medical devices. The upcoming summit will pull together some of the brightest minds in the industry to share insight and tips to ensure compliance as we take on another year of change.”

The EU MDR & IVDR Virtual Summit, as part of the True Quality Summit Series, aims to share perspectives, industry experiences, key actions and insights related to EU MDR & IVDR from top industry leaders.

The EU MDR & IVDR Virtual Summit is part of Greenlight Guru’s 2021 True Quality Summit Series. It is the third virtual summit powered by Greenlight Guru. In November of 2020, Greenlight Guru hosted its 2021 State of Medical Device Virtual Summit to assist medical device professionals in using quality as a strategic asset for growth. The virtual summit also comes on the heels of Greenlight Guru’s revolutionary product launch: Halo℠ for Change Management — the world’s first AI and machine learning recommendation engine for medical device quality.