There are many types of ISO. I’ll focus on ISO:13845 which is desgined to be used by the organization involved in the design, production, installation and servicing in the medical devices and has been revised every 5 years for the better quality of the devices. I will rather the ISO protocol for the medical devices because there are certain safety…[Read more]

Design validation is first stage for the device development and it’s most important stage. As the design of the device is made, the main job was to validate or else to check whether the design is proper or not. So the main issues Design validation face that the design validators should not be within the team, should be a external valditors that…[Read more]

Risk/Benefit ratio sometimes leads to gain more profit and sometimes may leads to loss for the medical device. Most of the companies in other sector takes risk in order to upgrade product, While in the medical field I have noticed that device takes a lot of time for the upgrade maybe the company want to stick same protocol, don’t want to take risk…[Read more]

Change in the project can give benefits or else may give major risk in the project. If the project is completed and in the last stage certain changes is made, firstly the due date of the project will gets affected and gets delayed. Gradually, the Budget also gets affected.

I was service engineer in Medtronic. I used to deal with Ventriculoperitoneal Shunt, Lumboperitoneal shunt, Neuro Drills. Neuro Drills used to make burr hole in the skull, so that Minimal Invasive Surgery can be performed. I used to go for breakdown calls for neuro drills, So the request that i got from the customers that the burr for neuro drills…[Read more]

Clinical project managers are responsible for organizing, communicating and evaluating team objectives for clinical studies. Their team might include clinical research associates and clinical specialists. Clinical project managers essentially plan and manage clinical trials in order to achieve quality results. They provide leadership in developing…[Read more]

Project integration management is a way of making various processes work together. Meaning, it takes the numerous processes that are being used in a project and makes sure that they’re coordinated.

Project integration management accomplishes this by making trade-offs. That means that you can’t have everything if you want to get the project com…[Read more]

This are some steps that project manager can handle budgets:-
Produce an estimate. Compile a realistic estimate with your team. Make sure it covers all the project’s phases and activities and that it contains sufficient contingency. Account for all people costs as well as materials, hardware and software

2. Achieve a baseline budget. Formally g…[Read more]

Change control is a systematic approach to managing all changes made to a product or system. The purpose is to ensure that no unnecessary changes are made, that all changes are documented, that services are not unnecessarily disrupted and that resources are used efficiently.
The change control process is usually conducted as a sequence of steps…[Read more]

Validation and verification should take place from the early to the final stages of our product lifecycle and even after the release of the final solution. The most commonly used methods are surveys/questionnaires, usability tests, card sorting, eye-tracking and a continuous monitoring of how users are responding and interacting with your product…[Read more]

Specs is determined during the test of the product accordingly to that the specs is also upgraded. As the product is fabricated there will be chances of some specs getting destroy in the manufacturing site. So that the reason product goes into multiple tests which comes out as final and better product.

Quality plan itself defines the quality of the product, which includes certain policies, documentation, procedures and tests for the medical devices. As the medical devices already overcomes with many researches and many test on animals as well as in humans. Then it goes into documentation and approval tests where quality requirements are taken…[Read more]

The medical device is generally categorized in three class:- class 1( Low moderate risk medical devices), class 2(low to moderate risk medical devices), class 3(moderate to high risk device). The categorization is been made by FDA. Every Single medical device comes in the market should follow this protocols.

Huge investment needed in medical device. Some of the small companies collaborate with each other for making a medical device. For instance, Medtronic are taking small companies like covidien just make profit and make a better product.The main reason for so large amount of funding required for the medical device because of so many tests performed…[Read more]

There are certain protocols given by FDA, Every manufactures should go through the protocols. The main purpose of the FDA is for safety measures. Even though, there is a flaw in the design of the product cause huge problems for patients

From my experience in Medtronic, My job was totally functional based system. I was a biomedical service engineer. I had to do certain tasks in a particular day. If there’s a emergency case in the hospital, I had to rush in hospitals and fix that issue. In future, I want to be in a project based system. I think whatsoever knowledge i gained in the…[Read more]

In order to initiate a big project, starting base level of that project should be a perfect team which plays a crucial role. For a perfect team, needs a perfect manager (leader). Team is like pyramid of project. If the project is half way towards completion and if the a particular team member gets back out, then either project is gets back out or…[Read more]

I think both interpersonal skills and technical skills are important in the biomedical field. For instance, If a engineer makes a medical device gradually he would be having more technical knowledge of that medical device. Now that engineer is planing to gain profit from that medical device. Here technical skills plays a major role in FDA…[Read more]