The different stages of project includes initiation, planning ,execution ,managing and control , closing. In the initiation phase of a project ,the project meeting are quite important which states the roles and responsibilities of individual working on the project it is important to bring all team member on same platform of understanding because…[Read more]

Interpersonal skills are as important as technical knowledge .Interpersonal skills are the way to how someone relate and communicate with other. Interpersonal skills are attributes that are used to motivates employees and how to make them use their knowledge to achieve the best results.Without interpersonal skill everyday business would be very…[Read more]

The risk management plan is a document prepared by project manager to foresee risks and methods to either minimize or eliminate their negative impact on project . An ideal risk management plan can solve any unexpected problem coming while executing the project because all the scenarios that can go wrong has been taken into consideration while…[Read more]

When bringing a medical device into market company will determine whether to submit 510(K) or PMA. If the company could not make right decision getting unsafe product in customer’s hands causes serious damage and product failure. The class II devices are important for healthcare but also have less risk to user requires 510(K) submission while…[Read more]

The company should invest in the project if it is making steps in right direction. Not every idea has the potential to turn into a viable business. Great idea needs to solve specific kind of a problem in order to be viable. There should be a clear image about the target market. Company will look to invest in great ideas hoping to make big amount.…[Read more]

The efficiency and outcomes of a project directly depends on the team who work on the project. However assembling right people for team is a critical task. For a successful project, the requirement of a project should be deeply understand so that people whose skills can fulfill those requirement can be selected as team members. The employee…[Read more]

A Quality Plan clearly defines what the quality management system is supposed to achieve. Quality planning means that you are going to make a device according to the project plan . Beside the project is completed on time and in budget since quality plays an important part means right product is deliverable to the customer . In Quality planning…[Read more]

The project manager for medical device company leads the team of engineer ,owns the relationship with clients and applying engineering knowledge to ensure successful outcomes . Assembling a medication reconciliation team is an important task for project manager for medical device company . The Design Team should be comprised of multidisciplinary…[Read more]

When a physician uses unapproved medical devices it risks the safety and health of patients. Such medical devices should not be available during regular clinical care. FDA recognizes the emergency use of a investigational devices in a immediate life threating situation when no standard treatments are available and there is no time available to…[Read more]

Labeling and packaging of product pay a great deal of attention to ensuring compliant with good manufacturing practices (GMPs) and FDA regulations. The manufacturers can’t afford to ignore errors in product labeling or packaging artwork or missing information. Mislabeling can cause misuse of product leading to serious effects. However the cost o…[Read more]

Stark law, is a complex set of regulations that has constantly expanded since its initial publication in 1995. Stark law restricts the physician from self referral patient to a designated place where he or his family members has a financial relationship unless an exception is met. It tends to eliminate any financial benefit to physicians through…[Read more]

The gift triggers a human instinct to reciprocate; even if the reciprocation involves nothing more than giving the detail person a few moments of your time.  It may be entirely reasonable to accept a small token of appreciation from a patient. In fact, refusing it may cause embarrassment that could unnecessarily harm the relationship between a…[Read more]

Danvers-based Abiomed, Inc. has agreed to pay $3.1 million to resolve allegations that it violated the False Claims Act by purchasing lavish meals for physicians in order to induce them to use Abiomed’s Impella line of heart pumps.  The United States contends that Abiomed sought to induce physicians to use its pumps, which cost more than…[Read more]

The matrix structure allows an efficient use of company’s resources. There could be some negative impact on project due to conflict between project manager and functional manager. The most difficult challenge in matrix form is team development. Every member in team must be informed about their role in project and they must be informed about the…[Read more]

The culture and structure of an organization can influence the way projects are managed and executed. If the organization follows a good, project management process, then chances of success of project increases . The project team member should know the effective ways to handle risks and other issues. The team members should be people with right…[Read more]

The reason for choosing the matrix in an organization is that functions and skills are fragmented throughout the organizational structure. Individual functional departments may face difficulties in solving very large problems because of a failure to view the total system and a tendency to sub-optimize or solve the problem within their…[Read more]

ALAPRP is ‘as low as reasonably practicable’. It requires weighing the risk against the time,cost needed to control it. Deciding whether the risk is ALARP is quite challenging because it requires the duty holder to exercise judgement. In a complex situation build on good practice are used to make formal decision that includes cost -benefit…[Read more]

The key to a successful risk assessment meeting is to be sure that the Risk Assessment Meeting includes Key Project Team Members and Key Stakeholders. By conducting a risk assessment meeting the Project Manager will be able to identify the greatest number of risks for a project. The project manager should review risk that happens in last project…[Read more]

Risk analysis is a tool to evaluating any risk or incident that can happen to the patients who are using medical devices. Risk identification is the important part the sooner, the risk are identified ,sooner methods or plans can be made to mitigate or avoiding the risks . Risk identification helps to identify the events in early stage which will…[Read more]

FDA investigators will determine if a design is appropriate, or safe and effective by evaluating the design control process, make recommendations based on whether the manufacturer has the required checks and balances in place, and verify implementation of the design control guidelines . Organizations should be remain creative, meet schedule team…[Read more]