Interpersonal skills and business skills both are important to make a good deal.Interpersonal skills are the way to how someone relate and communicate with other.Without interpersonal skill everyday b...

Funding problems that arises during an innovation project are one of the biggest obstacle to innovation.Financing of next innovation phases is no longer guaranteed.The objectives of technical feasibil...

When a component of equipment experience a failure,the nature and cause of failure should be investigated and analyzed.Root cause analysis is important to determine the cause of breakdown so that step...

Revalidation is required when the equipment is modified,relocated,or otherwise changed in a manner which may effect the process.Any change in the equipment need to be evaluated to determine the potent...

Moving equipment from one place to another,usually requires revalidation .Revalidation is needed to ensure that changes in the process or in process environment do not adversely effect process charact...

ECO’s make it possible to accurately identify ,address and implement product change while keepin all key stakeholders in the loop and maintaining a historical record of product.The change process star...

Dimensioning the QMS documentation based on organizational needs is essential for a functional QMS.The first set of QMS requires manuals,record ,procedure are required in simplest form.Small organizat...

PMS is a collection of processes and activities used to monitor the performance of a medical device.PMS can improve device,provide better services to users and reduce the risk of adverse events before...

SOP’s are step by step procedure how to do something that is critical to quality ,safe operations and security.SOP involves procedure and work instructions .The correct level of details required depen...

DHF contains all the design records from inception to launch and changes over time.DMR is one of the outputs from the DHFas It contains the specification that were developed during design process.Thei...

V&V demonstrates that design of a new product fulfills its requirement and meets user needs.A well defined requirement links to a customer need.Requirement should also be clear and measurable .Tra...

Design verifications confirms design output meets the design input requirement. Design validation establishing by objective evidences that design specification meets the user need and intended use. De...

DHF contains records necessary demonstrate that the design was developed in accordance with the approved design plan and requirement of the FDA’s design control.DHF contains detailed design plan,desig...

CE technical file and 510k are ensuring that medical device manufacturers produce and market safe products that comply the applicable regulation.Difference with CE technical file and 510k submission i...

It is easier to get device approval in EU than FDA.Regulatory process is less bureaucratic ,more efficient and more predictable than FDA.FDA requires both safety and efficacy of a device and it is bec...