Documentation control involves tracking document changes, revisions, and maintain of relevant versions company’s policies and procedures. This process...

What kind of regulatory pathway would be required for an antibiotic-releasing hip stem? CDRH Regulatory. Class 2 – Special Controls Is it a device, d...

combination product: Vosevi. It is use for treatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrh...

De Novo classification process involves new, novice unclassified devices using a risk based strategy to determine their class; class I, II or III. An ...

FDA is not rigid instead they're doing their best to protect public health by assuring the safety and efficacy of drugs. It will be devastating to its...

It's unethical but was the best method until recent when computer models are developed to simulate human biology. Animals like mice and rats share man...

Issues that would need to guard against when outsourcing an animal study to a university located about 1000 mi (1600 km) away from the company are as ...

An animal study is one of the most important steps in the process of translating biomaterials to clinical applications. But before going further to cl...

Industry projects are faster and tend to have higher rates of success due to large capital available for research and the quality level of experience ...

Working in the industry, not meeting project deadline happens all the time. As a product engineer in a reliability engineering department, obstacle fa...

Which phase of the project life cycle do you think is crucial to the success of a project? Explain. Which phase of the project life cycle do you find ...

Group of programs or projects are refer to Portfolio. The process used in execution of program or project is the strategy management. Portfolio manag...

A project manager for medical device will face the following challenges during the lifetime of the project; increase competition; other medical device...