Medical device quality management software (MDQMS) platform Greenlight Guru will be hosting a True Quality Summit Series: EU MDR & 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 15 through March 19, 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.
Failure to comply with the new MDR requirements from 26 May 2021 can negatively impact European manufacturers in a number of ways, such as products being withdrawn from market, costly fines, and even legal repercussions. Whether companies have fully transitioned, are just getting started, or are planning to enter the EU market in the future, the EU MDR and IVDR Virtual Summit will provide value to all by covering common questions, pitfalls and strategies for operationalising the requirements and applying best practices to ensure ongoing compliance.
Jon Speer, founder of Greenlight Guru, said: “In the current medical device landscape, companies cannot afford to fail regulatory compliance standards. 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. Core details of the regulation change, such as key dates, timelines, misconceptions and limitations related to the EU MDR, will also be addressed. This digital event aims to help attendees with:
- How to meet compliance requirements of EU MDR and IVDR before deadlines and maintain ongoing compliance
- Simplify the process of finding a Notified Body and understand how they will conduct audits under new regulations
- Meet new technical documentation requirements
- Learn about new scope of new economic operator requirements
- Comply with stricter clinical evaluation and post-market surveillance requirements while demonstrating total life cycle traceability
- Understand Brexit impact and how to capitalise on a new UK market
- Discover new ways to foster collaboration and promote innovation to streamline transition planning, execution and continued compliance
Eric Henry, virtual summit presenter and senior quality & regulatory compliance advisor at King & Spalding, said: “As a community of medical device professionals, we must take advantage of opportunities that promote compliance as a crucial element of innovation in the industry. Greenlight Guru has demonstrated a history of ensuring this topic remains refreshed and at top-of-mind among medical device companies through their industry resources, like hosting these free virtual events to offer valuable expertise from the industry’s top experts across their global network. Speaker insights from the True Quality Summit Series could be an important factor in a company’s journey towards compliance with EU MDR and IVDR."
