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…   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…   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…   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,…   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…   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…   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…   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…   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…   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…   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…   Read more»

The quality management plan is also an important part of DDP. The purpose of the quality management plan is to describe how quality will be managed throughout the lifecycle of the product. It also includes processes and procedure ensuring quality…   Read more»

New Zealand uses a classification system based on risk to the human body. Increasing risk is assigned to Classes I ,Ila, IIb, III, and AIMD respectively. In New Zealand, market entry does require listing your product in MedSafe’s Web Assisted…   Read more»

Design transfer is a complex process involves transfer an approved design into production. Every manufacturer should follow procedure to ensure that design is correctly transfer into production specification. Sometime the product team doesn’t understand or don’t have enough time to…   Read more»

Design verification is important for ensuring the success of a medical device. It demonstrates that the product is safe ,designed correctly and design input meets design output. Design verification should start at an early stage when design input are developed….   Read more»

Design controls are important for ensuring that medical device is safe and effective and meets user ‘s needs and requirement. However FDA design control regulations applies to class III and class II and also some class I devices , every…   Read more»

Clinical trials are done for testing of drugs and medical device and advanced treatment that would be available to human in future. Scientists are constantly working to find new and improved treatment for disease and their research can only be…   Read more»

Patients should have right to decide what they want to do with their data and samples but in these cases there are some legal complications whether a person have any right over samples or tissues that were removed from his…   Read more»

The CRA is responsible for initiation ,conduct of clinical trials and ensuring that scientific data have been collected and protecting the right and safety of patients. CRA should have a medical background because they are familiar working with patient health…   Read more»

Other color that is used by companies is orange it is mixture of drama of red and cheer of yellow . Being bright and friendly it is associate with the heat of sun and signifies aggression ,considered as confident brand….   Read more»