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 feasibility is to confirm that product will perform and to verify that there are no production barriers.It is an excellent tool for troubleshooting and long…[Read more]

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 steps can be taken to manage the cause and avoid them in future.In repairs and maintenance of equipment the Revalidation could be avoided but be sure to…[Read more]

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 potential consequences on validation status.The Revalidation may be required based on observed performance of equipment eastablished initial validation ,as…[Read more]

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 characteristics and product quality.when equipment is moved to a new location installation and operation should be re-qualified.By comparing data with…[Read more]

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 starts when someone identify an issue that need to be addressed with a change to the product.It ends when agreed upon change is implemented.ECO’s are use…[Read more]

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 organization focus on documentation should be simple and ultimate customer’s satisfaction .They can have documented procedure included in QMS manuals.The s…[Read more]

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 it happen.If manufacturer introducing new technology ,should respond with an increased monitoring program to ensure early detection of problems.Post…[Read more]

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 depends on task complexity, level of detail increases with task complexity.If user become more experienced they do’t need to be reminded of all basics all…[Read more]

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.Their difference resides in the phase of product life cycle ,DhFcovers the design phase and DMR is used during production phase .DMR contains information…[Read more]

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 .Tracing back to Requirement is a significant challenge when test fails.Regression test allow a consistent ,repeatable validation of each new release of…[Read more]

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. Design V&V demonstrates at product was design correctly. Process validation means establishing by objective evidence that a process produces a result…[Read more]

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,design input,design output,risk analysis,design verification and design validation and design transfer.Technical file describe the product at a point in t…[Read more]

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 is need to provide clinical evaluation reports.To put together technical file design verification and validation is required where as for 510k onl6…[Read more]

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 becoming more difficult to conduct clinical trails in th U.S.due to FDA’s clinical data requirement .CE only require proof of safety and device p…[Read more]

Guidance documents are the strongest documented consensus of how the directives are interpreted.Among the three guidance documents,NB-MED are the most useful documents.The duties of NB-MED are to receive technical dossier submitted by manufacturer,to assess the manufacturer quality management system,to evaluate evidences from lab ,clinical or…[Read more]

The PMOA for a combination device determines the lead agency center .The component that contributes the most to the combination device’s intended therapeutic effects determines lead agency center. If PMOA is unclear ,a request for RFD can be filled.This will help to established lead center of combination device.After receiving RFD ,FDA will a…[Read more]

Participation is the best practice for incorporating it into market strategy.Many companies are using social media marketing and business blogging in their market.Customers are more happy to give review on social media.online forums are also created by companies where customer are participating.Marriot international also create Facebook game My…[Read more]

Multi-center clinical studies poses significant challenges like communication across multi sites,multiple record keeping methods,clinical access for academic personnel.however the quality of data generated plays an important role in outcome of study.Clinical data management system has become essential to handle huge amount of data.The trail…[Read more]