Speaking to Advamed 2014 audience, the Commissioner tries to reassure device industry executives that the agency is working hard to ensure that U.S. is the leader for medical device innovation and manufacturing.
With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.
China’s rapidly expanding cancer market provides many opportunities for Western medical device companies.
Being in compliance means operating your business in a manner that means less risk, better quality, safety and governance. Compliance management software is designed to help foster this concept, so what do you need it to be?
There has been a lot of discussion about unannounced audits, and how companies need to prepare for these. But how can you prepare for something that you don’t know about? In this discussion, four industry experts offer some suggestions.
The QSR does not dictate how to execute a Receiving Inspection program; it only stipulates that purchased materials must be assessed for their suitability to be used in the manufacture of medical devices that are safe and effective in their intended use. It is up to the establishment to define their approach to RI.
Reform of the Japanese mixed medical treatment system should lead to increased opportunities for Western medical companies in Asia’s largest healthcare market.
Significant changes made to the design or processing of finished medical devices, that are safe and effective in their intended use, require the review and subsequent approval of FDA. This includes changes in the indication for use.
It is incumbent upon your organizations to ensure that the classifications of devices entered into commerce are properly classified and the applicable QMS requirements understood and implemented. Class I or Class II exempt has nothing to do with the actual QSR requirements and pertains only to the regulatory pathway.
In order to compete globally, companies must be proactive in their business plans and anticipate the challenges they may face, concur three med-tech executives.
