Medical Device
introduction
We Bring Excellent Medical Devices to Human Life
MontJade Engineering could produce Single-Use Implantable Medical Devices as well as their surgical kits. We support and serve customers to develop products from design ideas, essential requirements, to the best solutions of manufacturability in accordance with all unique requirements of each medical device. We design and develop medical devices sophisticatedly following design phase, testing, all the way to product validation.
MontJade Engineering implements product traceability system tracking production shop floor, warehouse all through to customers. We also have clean room operations to support product manufacturing, surface treatment, and medical device packaging.
MontJade Engineering provides quality and regulatory consulting services to customers. We produce medical devices to meet quality standards complying with all applicable customer’s specifications and international regulations.
Function Testing for Medical Devices
Torque Test- Dental Wrench
Universal Tensile Test
Salt Spray Test
MD Aging Test
Peeling Test of Medical Pack
Fatigue Test of Dental Implant
Pulling Test of Dental Implant
Dye Penetration Test
Quality Assurance System
ISO Certificates
ISO 13485
ISO 9001
GMP Certificates
GMP 1235
GMP 1277
International Medical Device Approval
FDA Registration
- ACCESSORIES
- IMPLANT
- DENTAL
- ENDOSSEOUS
- DRILL
- DENTAL
- INTRAORAL
- ACCESSORIES
- RETRACTOR
- DENTAL
- POST
- ROOT CANAL
- BITS
- DRILL
TFDA Certification
Orthopedic manual surgical Tools
Dental hand Tools
Root canal Post
Dental Implant Accessories
Oral Drills
GBR TiMesh Fixation System