Carefully conducted research can help a manufacturer successfully achieve strategic objectives.
The settlement is one of a few that the company has made within the past several months.
An electrical test failure code could cause the device to fail to initiate therapy.
The $701-million deal is expected to enhance Stryker’s cross-specialty surgical visualization for surgeons.
The initiative also focuses on how devices will be regulated in the post-market world.
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
IDE studies no longer have to rely on local IRBs; plus, changes are made to the patient threshold regarding HDE approval.
The approval gives high-risk patients a less-invasive treatment option.
FDA has categorized the recall as Class I due to the seriousness of the device issue.
The free resource recommends how hospitals can identify and safeguard medical device systems against an attack.