Section V – Recommendations and Economic Feasibility
The data investigation reveals that TQM theory underlies the FDA QMS regulatory framework, and using TQM while implementing a QMS will help the implementation team understand why the regulation is written the way it is, and how to create a company specific QMS. It is financially advantageous to implement a QMS system based on industry and researchers best practices, and the FDA has various resources for novice to advanced medical device QMS subject matters to assist small business leadership. Section V covers how the findings in Section IV may apply to Genovus, and provide specific recommendations to Genovus leadership. Finally, future research areas will be explored, as well as an discussion …show more content…
The cost of implementing a QMS is more than Genovus can currently afford, however understanding the best practice steps, and creating a QMS implementation plan based on current available resources, and a clear plan on how to create a QMS once funding is available is key. Not only does it provide clear direction for Genovus leadership today, it will show to potential investors that the Genovus leadership team understands the steps to implement a QMS. Genovus leadership should also take advantage of the numerous, and now catalogued, resources for small business. The Genovus leadership team should familiarize themselves with TQM theory, and Deming’s fourteen points, as this knowledge will help the Genovus leadership contextualize why the FDA QMS regulations are written they are. This context will speed implementation of the Genovus specific …show more content…
o Steps to migrate to a robust QMS once investment funding is procured.
Economic feasibility
The recommendations outlined specific actions based on current funding levels. The actions may also assist in procuring investment funding, because potential investors will want to know that the Genovus leadership team has the expertise and knowledge to implement an FDA level QMS system. This is required because Genovus financial projections assume FDA approval to sell in the U.S. market.
Implications for decision makers.
The Genovus leadership team is prioritizing many items as part of the startup activities. The QMS implementation plan should be considered a high priority because a QMS must be in place during all product development phases, even early stage. Failing to implement a QMS at this time may increase FDA scrutiny during the medical device approval process. In this event, the time to market for the medical device may go past the current top line financial projected timeline, therefore changing the long-term outlook for
The data investigation reveals that TQM theory underlies the FDA QMS regulatory framework, and using TQM while implementing a QMS will help the implementation team understand why the regulation is written the way it is, and how to create a company specific QMS. It is financially advantageous to implement a QMS system based on industry and researchers best practices, and the FDA has various resources for novice to advanced medical device QMS subject matters to assist small business leadership. Section V covers how the findings in Section IV may apply to Genovus, and provide specific recommendations to Genovus leadership. Finally, future research areas will be explored, as well as an discussion …show more content…
The cost of implementing a QMS is more than Genovus can currently afford, however understanding the best practice steps, and creating a QMS implementation plan based on current available resources, and a clear plan on how to create a QMS once funding is available is key. Not only does it provide clear direction for Genovus leadership today, it will show to potential investors that the Genovus leadership team understands the steps to implement a QMS. Genovus leadership should also take advantage of the numerous, and now catalogued, resources for small business. The Genovus leadership team should familiarize themselves with TQM theory, and Deming’s fourteen points, as this knowledge will help the Genovus leadership contextualize why the FDA QMS regulations are written they are. This context will speed implementation of the Genovus specific …show more content…
o Steps to migrate to a robust QMS once investment funding is procured.
Economic feasibility
The recommendations outlined specific actions based on current funding levels. The actions may also assist in procuring investment funding, because potential investors will want to know that the Genovus leadership team has the expertise and knowledge to implement an FDA level QMS system. This is required because Genovus financial projections assume FDA approval to sell in the U.S. market.
Implications for decision makers.
The Genovus leadership team is prioritizing many items as part of the startup activities. The QMS implementation plan should be considered a high priority because a QMS must be in place during all product development phases, even early stage. Failing to implement a QMS at this time may increase FDA scrutiny during the medical device approval process. In this event, the time to market for the medical device may go past the current top line financial projected timeline, therefore changing the long-term outlook for