Last seen: Nov 22, 2020
NDA's are legally binding documents so we should read it carefully before signing. We need to be aware of the terms in the document and clarify any va...
Alternative Dispute Resolution (ADR) can be effective because they are speedy than going to courtroom and also reduces the cost. Moreover the result c...
Consultants usually have experience of working in the domain of the developed Medical device and they can provide a viewpoint which the company realis...
My preference would be to work in a matrix structure because it can increase efficiency to meet the demands of the project by collaboration with vario...
When I worked as a Research assistant, there was matrix structure where I reported to immediate supervisor and project manager. As long as there was p...
The important trait of upper management in any industry is leadership quality. They foresee the future of company and set the vision for everyone to w...
The risk register is an important document in the product life cycle and it has to be updated continuously with the following information - Prior...
Like everyone suggested in the previous posts, Information Gathering techniques are proven for Risk identification. These techniques involve sessions ...
Some of the basic tools used are 1. SWIFT Analysis - Standing for “Structured What-If Technique” where the project members apply a systematic, team...
In combination products design controls, the clinical trials takes place as three constituents - for drug constituent part, the device constituent par...
Drugs trials are conducted in three phases, starting with an introduction on a small number of healthy subjects, and then in large populations and the...
Document control is very essential in device changes. It helps maintain a quality system or a device. An example of controlled device change is device...
Randomization is used to reduce the bias in assigning patients to study treatment groups and it provides unbiased assessment of the effects of differe...
As of January 2020, it has been reported that one patient with amyotrophic lateral sclerosis, or ALS, has received an investigational drug from BrainS...
Although I have never experienced Adverse effect during clinical trials, I agree to the possibility of incorporating wearable technologies into the pr...