Lake Region Medical
 
 
 
EXPERTISE: PRODUCT & TECHNOLOGY DEVELOPMENT
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Product & Technology Development Process Development Regulatory & Testing Commercialization
Product & Technology Development Services

Product & Technology Development

Lake Region Medical has the clinical, technological and device expertise to aid in the development of minimally-invasive delivery systems. An established history of developing vascular access and interventional products has given Lake Region a first-hand understanding of the challenges and solutions for products in the clinical marketplace.

Key Capabilities Include:
On-going research and technology for new product development, product improvement and manufacturing process improvement
Validation engineering test lab and clinically relevant testing
Pre-clinical study design and implementation
Extensive design and technology expertise (>100 engineers)
QSR compliant, phased development of projects
Product qualifications
Concept development / prototyping
ISO 11070

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Process Development

Process Development

Lake Region Medical is uniquely positioned with both the market knowledge to provide clinically-relevant input on product design and the engineering expertise that enables products to be manufactured in the most efficient, cost-effective and repeatable manner. Our New Product Introduction group offers a range of possibilities, from prototype manufacturing to clinical builds, and can develop a manufacturing process suited for high-volume, commercial manufacturing.

Key Capabilities Include:
Support for design and process optimization
Manufacturing volume to support clinical trials
Quick-turn, custom builds
Product and process qualifications
Product prototyping
Scale-up production

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Regulatory and Testing Services

Regulatory & Testing

Lake Region Medical offers in-house clinical and regulatory services to submit and gain regulatory approvals in any geography. We can obtain approvals for customers or for Lake Region Medical as the legal manufacturer. We have extensive test methods that not only suit FDA profiling, ISO 11070 standards but also ensure product capability. In addition, we have standing advisory boards of interventional clinicians who can provide product feedback and clinical recommendations.

Key Capabilities Include:
Pre-clinical data and design history
510(k), CE Mark, SFDA (China), Shonin (Japan) and other geographic submissions
Design history file compilation
Device master record management
Technical dossiers
PMA support
Clinical complaint management and failure analysis
Vigilance reporting
Repeatable, clinically-relevant test methods
ISO 11070 standards testing
FDA profiling testing
Clinician advisory board

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Commercialization Services

Commercialization

Lake Region Medical is a high-volume manufacturer of single and multiple-pack, sterile guidewires and finished delivery system devices. We currently manage bulk shipments to fill both purchasing and kanban orders in a dock-to-stock arrangement, as well as overseeing shipment and replenishment of finished products in customers’ warehouses through vendor-managed inventory programs.

Key Capabilities Include:
Stable lead times
Supply chain management
Customer-enabled portal access
Dock-to-stock and kanban programs
Continuous improvement program
Order-to-delivery integrated electronic records
Multiple packaging configurations (bulk, non-sterile and single-pack, sterile)
Product transfers
IFU development

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