It is more important than ever for medical manufacturers to prepare for business interruption due to unexpected damage or natural disasters. From building a recovery team to securing proper insurance, there are many steps device manufacturers can take to recover quickly and easily following a disaster.
Taking these compliance challenges into account will allow healthcare organizations to prepare for compliance audits, but more importantly it will help institutions address issues that result in a negative patient outcome.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
Improving clinical trial equity can help close the gap between the challenges to enroll and retain patients in clinical trials and the growing burden of diseases. All in all, there are immense benefits to creating and providing remote technologies for clinical trial participants.
Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use.
Gain insight into the notified body approach to assessing biological equivalence and how manufacturers can make sure their equivalence justifications pass notified body review.
Many younger employees need the interaction of in-person work. But to encourage a broader return to in-person work, organizations must make a compelling case for the benefits it brings employees. At the same time, they need to toss out the old office paradigm and transform to one that celebrates the new world of work.
Before product developers can more confidently design RWE studies and venture away from the traditional path of lengthy prospective studies, industry must overcome several challenges. This article provides insight on these barriers and perspective on how industry might fully realize the promise of RWE in the near-term to advance health care.
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.
Is technology replacing the human element in hospitals and clinics, or enhancing it? In this AAMI Research Review, a pair of newly published studies exemplify how accounting for the humans that use a technology can enhance its effectiveness… and vice versa.
