Technology Platform GMP Manufacturing
Technology Platform GMP Manufacturing
MeHow has a completed sterile medical device manufacturing system and capacity, with the production of class II sterile medical devices and class III implanted sterile medical devices experience, able to meet the needs of different clients for GMP manufacturing.MeHow has a complete sterile medical device manufacturing system and capacity, with the production of class II sterile medical devices and class III implanted sterile medical devices experience, able to meet the needs of different clients for GMP manufacturing.
GMP Site Management System
The most important aspect of sterile and implanted medical devices is the control of contamination, including particles, microorganism, chemical contamination, etc. A set of qualified manufacturing system is the basis to ensure medical devices are not contaminated, so as to ensure the safety and effectiveness of medical devices.
- GMP workshop hygiene management system
- Cleaning and disinfection management system
- Identification and traceability management system
- Clearance management system
- Batch record management system
- Product release management system
GMP Workshop
Hardware facilities are the basis of quality assurance for medical device manufacturing. BMV has a complete GMP workshop facilities to meet the requirements of class II and class III implanted medical devices manufacturing.
- Class 10k & Class 100k clean workshop
- Purified water production workshop
Laboratory Testing Capability
Clean room needs to be checked, and the environment has to be regularly monitored to ensure the production environment meets the requirements. Medical device products must be tested before release, to ensure the medical device meets the registered technical requirements and the requirements of laws and regulations.
- Environmental detection capability (particle, temperature and humidity, number of ventilation, pressure difference,sedimentation bacteria or planktonic bacteria)
- Physical performance test (size, weldingstrength, flow rate, leakage, heat sealingstrength, etc.)
- Microbiological performance test(initial contamination test, sterilization test)
- Microbiological performance test(initial contamination test, sterilization test)
Technology Platform Precision Manufacturing
MeHow has been deeply engaged in the field of precision manufacturing for medical devices, and has accumulated rich technology and experience. MeHow can meet customers’ comprehensive manufacturing needs of different medical devices, from medical device parts development to assembly of finished medical devices.
Precision Manufacturing Capability
- Precision plastic injection molding
- Precision LSR injection molding
- Medical extrusion molding (straight tube, threaded tube, double material threaded tube, sandwich threaded tube, etc.)
- Product post processing (ultrasonic welding, heat staking, pad printing, silk screen printing, hot stamping, laser cutting, laser marking, etc.)
- Medical precision metal parts processing (titanium alloy, nickel-titanium alloy, stainless steel, etc.)
- Manufacture of passive and active finished medical devices
Integrated Precision Manufacturing Technology Services
- Design, development and validation of manufacturing process
- Selection and validation of manufacturing equipment
- Design and development of high-speed mold
- Design and development of tooling and fixture
- Design and development of testfixture/jig/gripper
- Sample or prototype production
- Reliability test
- Mass production and inspection
- Turnkey engineering services
Technology Platform Material Engineering
Material engineering science impacts all industries, not only benefiting the R&D of new products but also significantly promoting the optimization and improvement of existing products. Research on the material engineering and science has enabled BMV to gain extensive experience in manoeuvring technological innovation and optimizing product costs.
Metal Materials
- Steel
- Titanium alloy
- Nickel-titanium alloy
Poymer Materials
- Plastic Materials
- Silicone Materials
- Polymer Composite Materialsalloy