Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.Continue reading "What Keeps You Up at Night? 2014 in Review for Medical Device Companies"
In the US, there are two regulatory processes used to obtain marketing clearance for a device. 510(k) is a type of premarket submission where there is a substantially equivalent predicate device. Without this comparison, the submission would require a PMA (Premarket Approval). This process applies to most class II devices. The submission must demonstrate the same safety and effectiveness characteristics of the predicate device. A successful submission results in the permission to distribute and sell. A PMA requires evidence from controlled trials to prove the safety and effectiveness of the device.
The submission process is challenging and it changes periodically so it is important to keep current. In December, the FDA issued draft guidance on how it tracks clearances that change ownership. This can happen when a product or company is divested to another. The FDA receives notification of this change but difficulties can sometimes arise when trying to trace the history. The electronic registry developed in 2012 facilitates this tracking. Regardless of the past ownership, there remain key issues to focus on when preparing the submission.Continue reading "510(k) Clearance Without the Snags"
Everyone knows that an organization has reporting requirements within their accounting departments, but an organization should think beyond financials and recognize that compliance is relevant to so much more.Continue reading "The Power and Flexibility of Dynamics AX in Compliance"
It seems with every key stroke, data is collected and stored by a third party. This huge amount of information may be a treasure trove for companies to learn more about the effectiveness of a treatment or the performance of a device. Some say it holds great potential for improving patient care. But like most big data stockpiles, others become squeamish at the thought of alternate uses for the data.Continue reading "Individualized Care, Big Data and Privacy"
Gartner recently released their ERP Magic Quadrant, and for another year Microsoft Dynamics AX has been left out of the Leaders Quadrant due to a perceived lack of the Partner Channel's ability to implement AX in a global, large enterprise. (See Merit Solutions' white paper: The Challenges of Working with the Wrong Consultant.)
Most organizations realize that choosing and installing an ERP system is too complex to be handled in-house. The process of adopting a new ERP system invariably involves working with a third-party consultant. In fact, the success of the deployment and use of an ERP system depends heavily on the quality of the consultant, so heavily that a business might consider bringing in other help if the project starts falling apart.
So what are some red flags that the consultant selected may not be up to the task?Continue reading "ERP Consultant Warning Signs"
When the FDA warns of further enforcement, it is not just an attempt to intimidate. There are teeth behind this procedure and companies need to stand up and take notice. Ignoring or excessively delaying a response will not make it go away, the ramifications will only increase.Continue reading "When it Becomes Criminal"
Continuing improvement of the 510(k) process took shape in late 2012. Medical device companies have been frustrated by the length of time it takes the FDA to review submissions. The agency believed that the state of some of the submissions was a contributing factor.
Enter the Refuse to Accept policy (RTA).Continue reading "The Road to Clearance - Avoiding Refusal"
When a company is considering replacing their existing or acquiring a new ERP system there is part of the entire process that sometimes is left out or left to chance: business process improvements and business process management. This is really a crucial part of any successful ERP implementation.
What are Business Process Improvement (BPI) and Business Process Management (BPM)? How are they different? How are they similar? What are the challenges and best practices with BPI and BPM? And why are they important to a global enterprise ERP implementation?
The purpose of this document is to outline the challenges and best practices associated with BPI and BPM initiatives - and how they related to new global ERP investments.
Read the white paper by Jack Toland, Senior Consultant at Merit Solutions: Business Process Improvement (BPI), Business Process Management (BPM), and How They Relate to New ERP Implementations
E-Health services and wireless, wearable devices are spawning new products regularly. Last year monitoring devices grossed $2.9 million and is expected to grow to $17.1 million over the next five years. There is increasing demand for expanding the old point of care paradigm from the traditional hospital/doctor’s office setting to a more mobile medical environment. With this expansion, come new challenges with compatibility, wireless performance, security and compliance with the somewhat fledgling regulations.Continue reading "E-Health Services: The New Boon"
Last year the FDA issued a draft guidance to clarify the difference between a recall and a product enhancement. Only voluntary recalls are in scope and whether they are performed by the manufacturer or at the request of the FDA is irrelevant. The difference is important as a recall requires the submission of a correction and removal report to the FDA. These reports become part of public record and thus may not put the company in a positive light. What may be considered recalls can include updates to instructions or changes to components or labeling.Continue reading "Recalling the Difference"