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 vague statements before signing. NDAs should provide...

Alternative Dispute Resolution (ADR) can be effective because they are speedy than going to courtroom and also reduces the cost. Moreover the result can be kept confidential in ADR whereas most court ...

Consultants usually have experience of working in the domain of the developed Medical device and they can provide a viewpoint which the company realises to see. Consulting an physician expert in the f...

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 various teams. This structure can also help to increase...

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 proper communication between the team member and su...

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 work towards it.Their leadership role can extend ov...

The risk register is an important document in the product life cycle and it has to be updated continuously with the following information - Prioritised list of quantified risks which were resolved T...

Like everyone suggested in the previous posts, Information Gathering techniques are proven for Risk identification. These techniques involve sessions like Checklist analysis where risks in previous de...

Some of the basic tools used are 1. SWIFT Analysis - Standing for “Structured What-If Technique” where the project members apply a systematic, team-based approach in proposal environment, where the t...

In combination products design controls, the clinical trials takes place as three constituents - for drug constituent part, the device constituent part and the combination product as whole. The implic...

Drugs trials are conducted in three phases, starting with an introduction on a small number of healthy subjects, and then in large populations and then in population with the disease or condition indi...

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 specification which will be be usually updated wi...

Randomization is used to reduce the bias in assigning patients to study treatment groups and it provides unbiased assessment of the effects of different medical treatments. Both randomization and blin...

As of January 2020, it has been reported that one patient with amyotrophic lateral sclerosis, or ALS, has received an investigational drug from BrainStorm Cell Therapeutics and seven patients have rec...

Although I have never experienced Adverse effect during clinical trials, I agree to the possibility of incorporating wearable technologies into the protocol for effective physiological monitoring. AE'...