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.
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?
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.
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.
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.
Mistake proofing is used in product, process, and service design and development as well as in ongoing operations and improvement applications. The goal with mistake-proofing is to find and correct mistakes, errors, or omissions as close to the source as possible, when the mistakes cost less to correct than if found later.
A surprise visit from FDA and a non-compliant QMS will likely result in devices being identified as adulterated. Entering adulterated devices into commerce in the United States may result in a warning letter.