According to 'Bryan Campbell article - Process Validation File': ' Process validation is standard for almost any medical component, regardless of classification. While we’ve all heard stories of valid...

According to 'Bonezone Article - Design Verification - Validation File', and FDA definition for Verification ' Verification means confirmation by examination and provision of objective evidence that ...

What do you mean 'Test-ab'?

I did research about the regulations in India, and I found that, India is one of the largest medical device markets in Asia, and is still growing at an impressive rate. Prior to 2005, no medical devic...

The regulation of medical devices across the world is very varied, ranging from comprehensive to none. Here in USA : Design Control – States that when manufacturers or suppliers develop a product subj...

From this lecture we have learned how to prepare our first DHF file, and as Dr.Simon mentioned about the DHF should contain some basic documents: PDF, DDP, DID - Business plan, market research - Risk ...

At a very high level, FDA wants to see that you have design procedures and plans established, that you have the appropriate documentation, that you have your design inputs or your design requirements ...

As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill....

For me, CRO, because CRO is like the “middle man” between the Sponsor and the research sites. CRO get hired by sponsor, I’d say about 90% of Sponsors use CROs because the Sponsor’s specialty is creati...

Having a clinical background gives a biomedical engineer ability to solve clinical problems. Biomedical Engineers work with a broad range of professionals ranging from other engineering specialties, t...

SWOT Analysis Philips Healthcare: Philips Mission "Improving people's lives through meaningful innovation." .Philips branches in 60 countries and they selling products to over than 100 countries.Phili...

Emotional intelligence (EI) is defined as the ability to understand our emotions and manage them effectively as well as to understand and effectively manage the emotions of other employees. Strong EI ...

A great example for the 5th P (Participation) in marketing, A pharmaceutical marketer intelligently stepped into the participation waters by offering patients ways to participate in treatment “communi...

Mission statement explains the company’s reason for existence. It describes the company, what it does and its overall intention. The mission statement supports the vision and serves to communicate pur...

Choosing the best structure for your business, depends on the the business needs. Probably the most important thing on choosing your company structure "TAXES".Because each business form comes with dif...