The major driving factor behind the growth of the medical device contract manufacturing market is the overall expansion of the medical devices industry, mostly owing to increased illness prevalence, life expectancy, and the elderly population. End users have been pushed by technological advances to rebuild or modernize their manufacturing systems. For medical device manufacturers the opportunity comes with the challenge of satisfying end-user customer satisfaction, regulatory compliance, consistency, and cost. Scaling up in-house expertise to design equipment, processes, and validate them in order to launch in conformity with regulatory standards are also very crucial.
Cephas Medical is an ISO 13845: 2016 certified, USFDA registered medical device manufacturer and exporter that has built a reputation for producing high-quality products. At CEPHAS, doing it right first time and every time is way of life. The company was founded by Thangiah Immanuel – Managing Director and B.S. Rajakumari – Director Quality in the year 2001 . Thangiah Immanuel has hands-on experience in the medical device industry in India and Thailand since 1989. While, the quality division is led by Rajakumari, who has extensive process chemist expertise. Both Directors have extensive
knowledge of USFDA 21 CFR 820 and other regulatory standards.
“We are continually looking for methods to bring value to our consumers and build credibility. We have a capable team of experienced specialists with competence in validation, process control, and equipment development among other areas. In addition, we have a new product development team that is solely dedicated to creating innovative products at the most cost-effective pricing range. Furthermore, we have the in-house capability to build equipment and scale up products for launch while meeting all regulatory requirements”, says Thangiah, Managing Director at Cephas Medical.
Cephas Medical has been successfully manufacturing a wide range of products such as Self Adhesive Male External Catheters, Plastic Molded Components (Medical, Electronics, Home, Cosmetics, and others), Amnicot (Gynecology product), Foot gloves, Nitrile Flock lined Industrial Gloves, Silicone Male External Catheters, and Specialty Dipped Products (in Nitrile, Silicone, Neoprene, Polyisoprene). In addition, the business has been working on Pharmaceutical Injectables.
We always focus on adding value to customers and create credibility. We have a competent team of seasoned professionals with expertise across validation, process control, equipment development among other things
Ensuring Strict Quality Standards
The organization continuously employs 5S and other quality tools to ensure that high quality requirements are satisfied. The ISO 13485 quality system with cGMP has been covering all quality control/assurance in every stage of the process, from vendor identification through auditing, incoming inspection, in process inspection, and final goods inspection. In addition, Corrective and Preventive Action (CAPA) is used to ameliorate the situation. Currently, the firm operates from two sites and plans to add another in the near future to meet the rising demand from global clientele.
"We will be adding many more product lines in the future, as well as extending the present product lines internationally. We will also join the pharmaceutical industry with niche products. As India has a high potential for CMOs, Cephas Medical will continue to concentrate on producing products with a strong emphasis on quality and consistency", concludes Rajakumari, Director Quality at Cephas Medical.
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