VLV Associates
Privately owned medical device development and contract manufacturing firm offering end-to-end services from concept and rapid prototyping through pilot production, packaging and validated manufacturing. Services are provided in Class 10,000 cleanroom environments and supported by in-house engineering, machine shop and testing capabilities. The company states compliance with FDA QSR (21 CFR 820), cGMP, ISO 13485 and related regulatory standards.
Industries
Nr. of Employees
small (1-50)
VLV Associates
Services
Concept evaluation, engineering design, rapid prototyping (3D printing), and prototype validation through to pilot production.
On-site manufacturing of medical device components, sub-assemblies and finished products in controlled cleanroom environments using automated assembly and custom fixtures.
Custom soft blister and form-fill-seal packaging, converting (lamination, die cutting), embossing and labeling including UDI/barcode printing.
Package integrity, leak and tensile testing, in-process and finished goods testing and process validation to support manufacturing quality.
Quality Management System operations aligned to FDA QSR, ISO 13485 and related regulations to support regulatory compliance and continuous quality improvement.
Concept evaluation, engineering design, rapid prototyping (3D printing), and prototype validation through to pilot production.
On-site manufacturing of medical device components, sub-assemblies and finished products in controlled cleanroom environments using automated assembly and custom fixtures.
Custom soft blister and form-fill-seal packaging, converting (lamination, die cutting), embossing and labeling including UDI/barcode printing.
Package integrity, leak and tensile testing, in-process and finished goods testing and process validation to support manufacturing quality.
Quality Management System operations aligned to FDA QSR, ISO 13485 and related regulations to support regulatory compliance and continuous quality improvement.
Expertise Areas
- Medical device development (concept to manufacturing)
- Contract manufacturing and assembly for medical devices
- Sterile device packaging and packaging engineering
- Design for manufacturing and production transfer
Key Technologies
- 3D printing (rapid prototyping)
- Form-fill-seal packaging
- Web converting and rotary die cutting
- UV bonding and light curing