Tuesday, 05 November 2019Todd Neal, Product Manager, IQVIA Quality Compliance
For any MedTech company, understanding and supporting a robust and finely tuned internal Quality Management System (QMS)
can be a competitive advantage rather than just a cost of doing business. And it’s imperative. Medical device manufacturers around the globe are required to maintain a Quality Management System to ensure safety and efficacy. Subsequently, they are also required to comply with regulations regarding Design Control to ensure that specific requirements for their devices are met.
Whether an organization is adhering to the FDA and its Quality Systems Regulation (QSR), the European Union and its Medical Device Regulation (EU MDR), or other regulatory authorities and standards for Design Control, it is important to manage the ongoing Quality Management process and provide documented evidence that a well-defined, controlled process is in place and has been properly executed. Under EU MDR, not only must technical documentation be current and demonstrate conformance with requirements, but it must also reflect the development stages applied to the design of the device.
Tuesday, 22 October 2019Caroline Freeman, Principal Consultant, IQVIA Quality Compliance
The MDR affects all medical device
manufacturers that sell to the EU, and its economic impact is already being felt, not just in the cost of implementing the new requirements for new products, but ensuring that legacy products meet the MDR, as there is no grandfathering from the current EU Medical Devices Directive (MDD). Manufacturers of all medical devices above simple Class I will need the services of an MDR designated Notified Body at some time between now and May 2024, with the exact timing being dependent on the validity of existing certificates to the MDD or the Active Implantable Medical Devices Directive (AIMDD).
Tuesday, 24 September 2019Kari Miller, Regulatory and Product Management Leader, IQVIA Quality Compliance
When implementing enterprise software, whether a Regulatory Information Management (RIM) solution, Quality Management System (QMS)
or an ERP system, the greatest predictor of its success will be how an organization manages the psychology of change. When an organization decides to implement new processes and/or new solutions, there are four phases of change that the organization is likely to experience: Denial (resistance), confusion, renewal and contentment. Hopefully the organization will experience all four phases if they are managing change properly.
Tuesday, 10 September 2019Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA
Today’s drug and medical device manufacturers have several common challenges. First, nearly all are being impacted by the shifting global regulatory compliance environment as they simultaneously strive to stay ahead of the competition while safely and effectively meeting the needs of patients. Additionally, compliance has typically been seen as a department, not a shared responsibility, and collectively perceived as a cost center, not a value center.
Tuesday, 27 August 2019IQVIA Quality Compliance
The capabilities of an enterprise Quality Management System (QMS)
have been shown to provide significant competitive advantage among Life Sciences manufacturing and service organizations. The right company for your Quality Management System will facilitate the production of superior goods and services, while also continuously supporting regulatory compliance. That’s why the QMS vendor vetting process is a critical first step toward success.
We asked a cross-section of IQVIA Quality Compliance
subject matter experts to share their perspective on the one question likely to draw the most insightful reply from a prospective vendor about how effectively that vendor will serve an organization. Consider these perspectives and think about how they might help you select a QMS vendor that will enable you to successfully attain your quality compliance goals.