Vitaimed Instrument Co., Ltd.

ABOUT US

Established in 2007 in Shanghai, China, Vitaimed is a leading medical device developer and manufacturer dedicated to advancing healthcare worldwide by developing, manufacturing, and marketing medical products that help improve the safety and effectiveness of patient care. Vitaimed product and service portfolio includes urological continence care, ostomy care, wound care, gynecological care, enteral feeding and irrigation products, and a full-service contract manufacturing business. Vitaimed products are with ISO13485, CE and FDA certificate. Vitaimed products are distributed in the United States, Germany, Greece, Italy, France, Spain, Portugal, Poland, CZ, Singapore, Thailand, Malaysia, Egypt, U.A.E., Korea, Brazil, Chile, Panama, S.Africa, Mozambique, and more than 40 other countries worldwide.

 

COMPANY CULTURE

Vitaimed Instrument Co., Ltd.

DEVELOPMENT 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 CENTER

R&D  Center

Vitaimed Instrument Co., Ltd.

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.

Vitaimed Instrument Co., Ltd.

 

QUALITY POLICY

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 Instrument Co., Ltd.                            Vitaimed Instrument Co., Ltd.                            Vitaimed Instrument Co., Ltd.

 

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.

COMPANY CERTIFICATE

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 Instrument Co., Ltd.

 

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

 

Vitaimed Instrument Co., Ltd.

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