Vlv Associates, Inc.
Privately owned contract developer and manufacturer of medical device products. Offers end-to-end product development from concept and prototyping through pilot production and finished product manufacturing, with on-site engineering, machine shop and testing capabilities. Operates controlled cleanroom manufacturing and packaging facilities and maintains a documented quality management system aligned to FDA and international standards.
Industries
N/A
Nr. of Employees
small (1-50)
Patents
Services
Concept development, prototyping, in-house testing and preparation for pilot manufacturing.
Contract production of components, sub-assemblies and finished sterile devices using automated and manual processes in controlled environments.
Custom soft blister and form/fill/seal packaging, converting operations, labeling and UDI/barcode printing for terminally sterile and non-sterile products.
In-process and finished-goods testing, package integrity and material testing and process validation to support product release and quality control.
Operate under an established quality management system aligned to FDA 21 CFR 820, ISO 13485 and relevant international regulations; facility registration with FDA.
Concept development, prototyping, in-house testing and preparation for pilot manufacturing.
Contract production of components, sub-assemblies and finished sterile devices using automated and manual processes in controlled environments.
Custom soft blister and form/fill/seal packaging, converting operations, labeling and UDI/barcode printing for terminally sterile and non-sterile products.
In-process and finished-goods testing, package integrity and material testing and process validation to support product release and quality control.
Operate under an established quality management system aligned to FDA 21 CFR 820, ISO 13485 and relevant international regulations; facility registration with FDA.
Expertise Areas
- Medical device product development
- Contract manufacturing and assembly
- Packaging and converting for sterile devices
- Quality management systems and regulatory compliance
Key Technologies
- Class 10,000 cleanroom manufacturing
- 3D printing (rapid prototyping)
- UV bonding and light curing
- Ultrasonic welding