DEDICARE  CONSULTING
PARTNERING for success
 
 

SYSTEMS DEVELOPMENT AND VALIDATION


With expertise in all aspects of the system life-cycle, Dedicare can help you develop and validate your manufacturing systems including Facilities, Utilities, Equipment, Processes and Test Methods.  

 

PROCESS DEVELOPMENT

Dedicare is familiar with the latest tools and techniques for process development and improvement including: DOE, Six Sigma, Lean and Risk Management (FMEA).  Dedicare provides Process Engineering Management services rooted in 17 years of hands-on process development, improvement, and leadership.  Tap into the manufacturing experience from a diverse group of products and manufacturing technologies.

Products:

Atherectomy Devices Catheters Guidewires
SS and Nitinol Stents Drug Eluting Stents Orthopedic Implants
Glucose Monitoring Angioplasty  Laparoscopy

                                                         

Manufacturing Technologies:

Manual Assembly Stent Crimping Centerless Griding CNC Machining
Welding (laser, plasma, RF)   Laser Cutting Electroploshishing Microblasting
Honing Coiling Swaging Vapor Deposition
Spray Coating Extrusion Molding Drying  
Tumbling Packaging  Filling Formulation   
Label Printing Pressing and Forming    Polymer Coating Cleaning

 

TEST METHOD DEVELOPMENT

Dedicare can help you select the appropriate test method, validate it and implement it.  Dedicare is familiar with the following measuring equipment and methods:

Pull Testing Vision Systems Coordinate Measuring Systems Visual Inspection
Go/No Go Gaging Calipers Indicators   Gage Blocks     
Micrometers Pin and Ring Gaging Comparators ...and more    

 

SYSTEM VALIDATION

Recognized by peers as an expert in all aspects of systems validation (IQ, OQ, PQ, PPQ), Dedicare provides full service including the development of the governing quality procedures, assessment, validation master planning, and remediation.  In addition to process validation, Dedicare also has expertise with Utilities and Facilities qualification (FAT, SAT, Commissioning), Test Method Validation, Cleaning Validation and Software Validation.