Vitaimed is committed to customer satisfaction and patient well-being.

All products and services provided to our customers are safe and effective for their intended use.

Each product and service is designed, manufactured, marketed, and delivered in compliance with all applicable laws, regulations, and standards.

Product quality is achieved through the consistent implementation and maintenance of an effective Quality Management System.

Every employee is responsible for actively promoting and implementing Vitaimed’s Quality Policy within their respective job functions.

VITAIMED’s quality philosophy is to achieve product excellence 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 full adherence to Good Manufacturing Practices (GMP) on a daily basis.

VITAIMED products are manufactured in strict accordance with 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 strictly controlled. The environmental control system is inspected on a regular basis.

Personnel sanitation rules are strictly enforced, and sanitized clothing is required for entry into clean rooms. Measures are implemented 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 must be built in from product conception and ensured through raw material testing, in-process production controls, and finished 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 products;

3. Approval of products manufactured, processed, and packaged;

4. Audits of the quality assurance program to verify compliance with established quality requirements.

All quality audits are performed by trained personnel who do not have direct responsibility for the products being audited. Audit results are documented in written audit reports and reviewed by management responsible for the audited products. Follow-up corrective actions, including re-audits of identified deficiencies, are implemented when necessary.

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.

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