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.
Japan’s Growth Strategy Promotes Medical and Healthcare Reform
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.
Executives Offer Prospects for Med-Tech Business Model
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.
One concern we frequently hear is absorbing the expense associated with training and then key employees departing the organization for greener pastures after their training has been completed. But what about the costs associated with mistakes and errors employees make, when employees are not properly trained and decide to stick around?
Top 10 Reasons for FDA Warning Letters to Medical Device Firms
The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.
Unannounced notified body audits are nothing new. Unfortunately, because of one really bad apple in the industry and a perception of the regulatory environment in the EU lacking teeth, the Commission has come up with an unrealistic and expensive solution for industry.
EU Device Regulations – What’s Changing and What Will Be The Impact?
What’s changing in the medical devices and in vitro diagnostic regulatory landscape in the European Union, and how can you effectively navigate these changes? This article offers an overview.
India’s Growing Cancer Market Offers Opportunities to Device Companies
As India’s cancer burden grows, the Indian cancer diagnostic and treatment market offers many opportunities for Western medical device companies that make such products. To succeed, Western companies need to develop their strategies in India carefully.