The government alleges that the company did not disclose serious health events in certain implantable defibrillators.
The agency action includes all non-NIOSH-approved disposable respirators, including imported KN95s.
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
Adding wireless connectivity to medical devices brings convenience to patients, and can facilitate more effective healthcare delivery and lower healthcare costs. Its success depends on the ability of manufacturers to produce reliable, connected products that do not fail prematurely in the field.
Recent transportation challenges have affected the medtech industry’s ability to deliver healthcare products.
Audits for medical device companies and other organizations in the medtech space used to be primarily in person. However, the pandemic magnified flaws in the global regulatory process. A shift to remote audits may be the key to interorganizational and international regulatory harmonization moving forward.
FDA also supports the removal of the HeartWare HVAD System from the market.
The utilization of reprocessed medical devices can help cut down the increasing cost of healthcare for consumers while also tackling device shortages.
The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
Nearly 32,000 stent systems have been recalled in the United States.