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Launching your product the right way

The New product introduction process is further added on to make our client’s product launch impeccable and innovative. While being in full compliance to the ISO 13485 standards and FDA standards, the stage gate approach is utilized to help streamline the entire launch process. The product is launched keeping in the best possible way, with respect to your goals, objectives while ensuring that everything falls in our client’s budget. 

Professional guidance through the launch process: 

Professionals in the field of manufacturing of medical devices are an integral part of the Integra Biomedical Group. Their expertise act as a great asset to the client, generally and specifically through the launch of their medical product. These professionals minimize the risks that might hinder the launch process. Availability of the required materials, suitable documentation and being in loop with the capacity of the resources , the experts take care of all that and more. This all inclusive approach gives our company an edge over the others in the field, since the Integra biomedical team will predict any risks and prevent them before they create a costly hindrance. 

How our launch process works: 

Our launch process of medical devices comprises various stages and phases. As soon as a client comes to us, we work with them readily to understand their expectations and objectives. Our team of skilled workers then collaborates with the customer to understand and improve on the set goals and the timeline of production. A program manager keeps in contact with other focal persons of every involved department as well as the customer. The product launch process is continuously improved upon by the manager till it becomes absolutely perfect. The initial design is reviewed, analyzed and every aspect such as the schematics, the regulations and the drawings is put under thorough analysis. 

Since the launch process is divided in phases, every step is taken after the previous phase has been thoroughly inspected and given the green signal. An important thing to note here is in order to ensure we meet the timeline requirements, flexibility can be demonstrated in the stages and phases, this allows our team to cover all the critical aspects in due time.  

The project manager refers to our team of experts and keeps an eye on the whole process of the product launch. While the process undergoes through the various stages and phases, adequate records of each stage are maintained and every person involved in the process is held accountable for the jobs assigned to them. Through this process of adequate documentation, accountability and maintenance of checklists it is made sure that the process goes forward without any hurdles and the risks related to the project, if any,  are addressed at the appropriate time.

The Project Manager and team of experts is responsible for approving the checklists and making it certain that all the required standards are met in each phase. A record of All the process and progress is maintained in a single document. Every step of the whole process is checked by a team of experts belonging to different departments consequently ensuring accountability at every step. Once you entrust your medical device procedure to us, you can be certain that your product will come out to be at the top of its game