Post-marketing vigilance reporting for medical device manufacturers, a crucial area for medical device manufacturers; is one of the areas in which professional trainings are provided in the areas of regulatory compliance, human resources, healthcare and IT, offers trainings for professionals.
Post-marketing vigilance reporting for medical device manufacturers is a very important, yet often overlooked areas for medical device manufacturers. But regulatory bodies are cracking the whip by introducing more and more stringent requirements for the post-marketing vigilance reporting for medical device manufacturers.
More legislation means more vigilance
Post marketing surveillance has now become stricter, and medical device manufacturers should be compliant with these requirements to stay compliant. In the event of failure from medical device manufacturers to comply with these requirements; regulatory bodies such as the FDA and the EMA impose heavy penalties on them. Trainings help professionals in the medical devices industry get a hang of how to prepare for post-marketing vigilance reporting, so that they can avoid harsh actions from the regulators.
“Regulatory bodies are in the process of continuously introducing legislation that is aimed at raising the bar for post-marketing vigilance reporting for medical device manufacturers. Their requirements keep getting updated from time to time. In the event of such actions from the FDA; medical device companies cannot afford to remain complacent. They need to keep updating their reporting systems to reflect these changes.
The aim of our trainings is to equip medical device professionals understand the content, nature and interpretation of these legislations. With a thorough understanding of all these; they are able to manage their post-marketing vigilance reporting better and are able to show higher level of regulatory compliance. As a result, they attract far fewer penal actions from the regulatory authorities”, claimed Satisha Naraharimurthy, Founder and CEO of NetZealous LLC, Fremont, CA: August 12, 2016
Trainings to cover controversial aspects
Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous LLC, says that the need for professional trainings in post-marketing vigilance reporting has become a big need for medical device manufacturers in the light of the passage of the MEDDEV 2.12-1 rev 6, a revised medical device guidance document on post-marketing vigilance in Europe, which came into effect from January 1, 2008. “This makes the exercise of a post-marketing vigilance reporting for medical device manufacturers more stringent and broader. With changes being brought about into the definition of many important terms such as “periodic summary reporting”, “trend reporting”, “advisory notice”, “near incident”, and “recall”; there is a greater need for medical device professionals to stay updated. Our trainings offer just this. Our trainings also offer clarity on the many controversial aspects of this requirement, as well as familiarization with the Global Harmonization Task Force (GHTF), CE mark, European Competent Authorities, and many more. With the help of these trainings, medical device professionals can bring about regulatory compliance with greater ease”, said he.
In addition, Manzoor says, NetZealous LLC’s trainings offer perceptive insights into the major determinants of medical device approval, such a innovation, the extent of changes to device or usage, risk factors involved in these, the type of procedure that goes into a medical device, the population that is being targeted, the safety of the device, the findings of the post-market surveillance findings, the emergence or discovery of new information regarding the safety or performance of the medical device, the elements of CE marking and so on.
Understanding of the requirements of all regulatory bodies
Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous LLC believes that these trainings are very important for medical device professionals because while the new European requirement is one of the areas in which professionals who work for companies that market their medical devices to Europe need an understanding of; there is a host of such requirements from the FDA. These too are quite complex and vast, requiring professional trainings to help compliance with. “It is necessary for professionals to get help in the form of trainings from a reliable provider of these trainings, such as NetZealous LLC. We aim to help them with their post-marketing vigilance reporting, no matter which market they are selling their product to, or the provisions of which regulatory bodies they need to show compliance with”, he said.