Manufacturing

We help you identify the best manufacturing for your product and ensure a successful transfer of new manufacturing or optimization of existing manufacturing lines. A more complete list of our services includes:

Contract Manufacturer Selection / Negotiation
Device Transfer to Contract Manufacturer
In-House Manufacturing Development (NPI)
In-House Manufacturing Optimization
Component to Finished Goods Strategy (sub-suppliers / assemblies)
Product Design for Manufacturing
Sustaining Engineering
Cost of Goods Analysis and Reduction
Manufacturing Scaling
Compliance Assessment

Supply Chain

Supply Chain has become extremely difficult to source on-time and on-budget, if at all. Let us help you build or optimize your supply chain.

Vendor Selection (including wide network of existing medical vendors)
Contract Negotiation
Fulfillment Optimization
Shipping Automation
Difficult Component Procurement
Lead-time Reduction

Quality

In order to be an excellent Medical Device company, you need a robust Quality System. We help you develop or maintain a system that meets requirements while providing excellent benefit to your company.

Quality System Review (ISO 13485, 14971, MDSAP, MDR, FDA CFR)
Department Optimization (Personnel, Systems/Procedures, Controls)
Audit Guidance and Assistance (ISO, FDA, MDSAP Countries)
Risk Analysis
Design Controls
CAPA Guidance and Implementation
Process Validation / Verification
Supplier Quality Controls
Complaint Handling

Regulatory

We have built a team of experts that can help you with your new submission or maintenance of your current submissions to maintain state of the art

510k Submission Help
EU MDD Tech File to MDR Technical Data for Submission
Product Design Regulatory Planning

Information Technology

The backbone behind every business is their Information Technology platform. We provide in-depth analysis and support for your IT backbone to give you a pathway to information success.

Existing System Analysis to Optimization
New System Selection / Consolidation
ERP Optimization
Salesforce.com Expertise (administration, configuration, training, maximizing benefit)
Systems Integration
Compliance
Process Automation (paper to electronic, manual process elimination, etc)
Configuration Management
Help Desk Establishment and support
Server Support
Security Assessment and Support
Cloud Migration
Telecommunication Support

Business Operations

Looking for an outside perspective or method to shore up deficiencies in your business processes? Let us talk to you about our expertise:

Departmental Integration
Process Optimization
Data Intelligence through Data Mining
Cost Containment
M&A Analysis (selling or acquiring)

If you do not see a service that you need here, please contact us for more information. We have a very wide span of expertise and have a vast array of Med Device connections that we can call on.