Documentation control involves tracking document changes, revisions, and maintain of relevant versions company’s policies and procedures. This process takes significant amount of time when manaully do...

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

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

De Novo classification process involves new, novice unclassified devices using a risk based strategy to determine their class; class I, II or III. An application drafted by Medical Device Sponsor is s...

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 mission statement if a life-threatening product i...

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 many physiological and genetic similarities with huma...

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 follow; Poor study design, time management, not en...

An animal study is one of the most important steps in the process of translating biomaterials to clinical applications. But before going further to clinical trials, ISO 10993 standard will be ran to f...

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 team of engineers and scientists put together to w...

Working in the industry, not meeting project deadline happens all the time. As a product engineer in a reliability engineering department, obstacle faced was design failed to work and new design team ...

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 least important? Explain. To answer your first que...

Group of programs or projects are refer to Portfolio. The process used in execution of program or project is the strategy management. Portfolio management focus in identifying, prioritizing, and aut...

A project manager for medical device will face the following challenges during the lifetime of the project; increase competition; other medical device companies are also working on similar product and...