About Us
Company Profile
Vitaimed Instrument (Changzhou) Co., Ltd., established in September 2007, is an international enterprise integrating the design, production, R & D and sales of medical devices. With more than ten years of development, VITAIMED has established good cooperation relationship with global medical partners, providing high-quality medical products and services for global medical partners, and providing corresponding clean workshop and supporting intelligent medical product production and research and development solutions for medical production and laboratory establishment.
Through the mature design and development advantages of VITAIMED GmbH (Germany)the global market and sales channel advantages of VITAIMED INSTRUMENT (Shanghai) Co., Ltd., the in-depth integration and innovation of production, R&D of JIANGSU UNIVERSITY OF SCIENCE AND TECHNOLOGY, and the domestic perfect intelligent processing support,VITAIMED SMART® help our customers to achieve intelligent, scientific and technological, become a strong backing for their medical safety and efficient production.
The company will actively catch the development opportunity of automation transformation of overseas medical consumables manufacturing enterprises, continuously improve the technical level of the company, develop intelligent equipment that can improve the assembly efficiency and product quality of consumables, and strive to become a global leader in the field of medical consumables intelligent equipment.
On the basis of consolidating the existing business, the company will actively explore the intelligent equipment market of high-value medical consumables in other subdivided fields, such as orthopedics, pharmaceutical equipment combination, etc., in addition to tube extruder, bag type, high-frequency heat sealing, mold development, epidemic prevention materials, mask machine, melt blown cloth machine, infusion medical consumables, and blood purification The system technology, constantly optimize and improve the GMP data management platform system, to create a digital workshop for customers and realize intelligent production; strive to make use of the unique advantages in intelligent equipment, share customer resources, selectively extend down to some high-value consumables core parts field which are still monopolized by foreign countries, provide equipment for customers and provide some parts for customers To solve the technical problems of customer production, reduce the production cost of customers, and further deepen the cooperation between the two sides. The company will continue to focus on overseas customers and channels, expand overseas markets more actively and steadily, and enhance the company's sustainable profitability.
Company Culture
Our Brand Core Values
Our Core Concepts
Our VISION and MISSION
Groth Path
2003
Started the economic urine bages business in Changzhou
2007
Vitaimed Instrument Co., Ltd. (Changzhou)established\Manufacturing Facility of Changzhou factory (5000㎡)Vitaimed Instrument Co., Ltd. (Shanghai headquarter for marketing and R&D) established
2008
Vitaimed Quality Control System operated according to ISO 13485:2003 by NQA, products are with CE markVitaimed brand registered successfully
2011
Vitaimed Quality Control System notify body changed to be TUV-SUD(Germany)and operated according to ISO13485:2008, CE by TUV-SUD(Germany)and notify body No.0123
2012
Vitaimed registered in US and obtained FDAListing included Continence Care and Urological Care etc...
2013
Vitaimed's own brand covered continence care ostomy care, wound care and gynecological care
2014
Vitaimed brand got the protect from 18 countries under the Mandarin's Terms of intellectual property rightVitaimed Quality Control System operated and updated according to ISO13485:2012, 9 products with CE marked CE marked list registration in EU
2016
From2007, 10years development, Vitaimed has already attent and participated main medical exhibitions all over the world, Medica(Germany),Fime(USA),Mordern hospital(Japan), Arab Health(Dubai), Hospitalar(Brasil),African Health(South Africa), Kimes(South Korea), Medical fair(Thaliand), Medical fair(Delhi and Bombay), Medical fair(Singapore), CMEF(Shanghai, Shenzhen)
2017
Vitaimed Quality Control System operated and updated according to ISO13485:2016 Till 2017, Vitaimed InstrumentVitaimed has been gotten 10 more certificates of invention patents, utility model patents and deign patent...
2019
VITAIMED created R&D center and registered ostomy bags & components, urine drainage bags, male condom, waste collection bags in China for domestic market
R&D System
Vitaimed has formed and internationalized R&D structure, enhanced its strong R&D capabilities, and established an interactive and integrated R&D system in China, the Germany, etc.
At the end of 2019 ,Vitaimed had a total of 25 projects: 8 ostomy care, 5 biological innovative materials, 5 continence care can meet international standards,3 Urology care coating technology, and 2 wound and skin care and 2 electronic hospital and caring bed.
Production Capacities
Our smart machines have been used on different medical solutions which can meet medical standards.
Vitaimed is committed to customer satisfaction and patient well-being.
All products and services provided to our customers shall be safe and effective for their intended use.
Each product and service shall be designed, manufactured, marketed, and delivered in compliance with all applicable laws, regulations, and standards.
Product quality will be accomplished through the consistent implementation and maintenance of an effective Quality Management System.
Every employee is responsible for the active promotion and the realization of Vitaimed quality policy within their job functions.
VITAIMED's quality philosophy is to achieve product perfection and customer satisfaction through the implementation and maintenance of an effective, stringent, and rigorous quality assurance system. Quality assurance plays a key role in the production of medical devices in partnership with full adherence to Good Manufacturing Practices (GMP) on a daily basis.
VITAIMED products are manufactured in strict accordance with the GMP Regulations and ISO standards. All parts, components, and materials used in manufacturing are received, stored, and handled in a manner consistent with our high quality standards. VITAIMED products are manufactured, assembled and packaged in air-filtered, temperature-controlled clean rooms, free from contamination. To ensure uniform environmental conditions at our manufacturing sites, temperature, humidity, air pressure, air filtration, and lighting are all strictly controlled. The environmental control system is inspected on a regular basis. Personnel sanitation rules are strictly enforced, and sanitized clothing is required for entrance to clean rooms. Measures are taken to prevent contamination of equipment, components, and finished products by cleaning agents and other chemicals. VITAIMED products are stored in clean, well-maintained warehouses.
VITAIMED's quality assurance program is founded on the belief that quality has to be built in from product conception, and ensured through raw material testing, in-progress production controls and end-product inspection. In brief , this program consists of the following procedures:
1. Review of product production records;
2. Approval of parts, components, packaging materials, labeling, and finished product;
3. Approval of product manufactured, processed, packaged;
4. Audits of the quality assurance program to verify compliance with the quality assurance program.
All quality audits are performed by trained personnel not having direct responsibilities for the products being audited. Audits results are documented in written audit reports, and reviewed by management responsible for the products audited. Follow-up corrective action, including re-audit of observed deficiencies, is taken when indicated.
VITAIMED values its commitment to quality and prides itself on its quality assurance system.
QA & RA Strategy
Maintain FDA QSR/cGMP compliance.
Maintain ISO 13485 & MDD certification.
Obtain CMD/CAS ISO 13485 certification.
Establish higher quality standards in world-class manufacturing.
Prevent & reduce product deficiencies from R&D through distribution.
Move toward six-sigma quality.
Production Capacities
VITAIMED is avertically integrated company with the following features:
· ISO13485 certification
· CE certification
· FDA registration
· Strict GMP compliance
· State-of-the-art manufacturing equipment
· Over 0.5million square feet of manufacturing space
· Medical class cleanrooms(Class 10,000 and Class 100,000)
· A well trained and highly skilled work force, over 1000 employees
· A talented engineering and R&D team
· An experienced management team with strong commitment to quality, excellence, and service.
VITAIMED's manufacturing capabilities include, but not limited to:
Tubing molding
Injection molding
Insert molding
Blow molding
Radio frequency(RF) sealing
Ultra sonic welding
Aseptic filling
Assembly in cleanrooms
Form fill seal packaging
Laboratory testing
Device design & development
Reverse engineering
ETO sterilization
+86 139 1863 8349
+86 21 5839 9546
+86 21 5839 9546
HQ Add.: Room 1601 Haibo Bldg.| No.101 Nanmatou Road | Pudong New District Shanghai 200125 China
Manufacturing Facility Add.: No.26 Huashan Middle Road, Changzhou, Jiangsu Province 213022 China
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