Medical device industry is the leading sector among the dynamic sectors that has shown rapid development in recent years. New companies are established almost on a daily basis for the manufacturing of novel medical devices or more sophisticated versions of the available ones. Often, most medical device companies are established by entrepreneurs who prioritize product concept and design but lack manufacturing experience. Furthermore, computerized equipment, complex software development and validations, molding models required for medical device manufacturing are all expensive components.
Two criteria become prominent for us in medical devices manufacturing:
Efficacy and Quality Considering competitive nature, like in many other sectors, efficiency is critical for the manufacturing of the medical devices for releasing the product to the market to maintain a competitive edge, the manufacturer must seek approval from regulatory authorities, a critical aspect, for the sale and marketing of the products in efficient and timely manner.
Often, the most overlooked situations in medical device manufacturing are related deficiencies in manufacturing sites.
Design, construction, approval, validation, qualification, operation of the sites are of critical importance, starting with the R & D stage of the medical device and continue to the life-cycle.
Manufacturers try to address most of the medical device development stages by outsourcing and contract manufacturing companies which must also consider meeting the same efficiency and quality requirements as mentioned earlier.
The most important point to consider in medical device manufacturing sites is the assessment of the design of working areas and efficient use by risk-oriented (ISO 14971, ISO 13485, FDA 21 CFR 820) approaches at the beginning stages of the project.
Working areas are spaces in which many components of medical device parts are gathered and installed, and their efficiency and productivity is directly correlated with their design forms.
You, as a client, in consultation with our team of technical experts would decide whether medical device manufacturing areas be of “U” or “O” shape As a solution partner, the team would work with you thorough out the product life-cycle.
In contrast with many other companies, we provide not only site design, but we also perform site construction.
We provide turnkey services with an objective that whole project is completed from one single source.