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...

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...

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...

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 Proje...

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 ...

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 c...

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 inc...

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 list...

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 speci...

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 sh...

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 ...

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...

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 ...

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 backg...

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 ,consider...