United Healthcare
Phone: (714) 364-5229
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EXPERT CONSULTANTS
Our expert consultants and the solutions we provides:
Engineering: Electrical, Chemical, Mechanical, Civil, Environmental, Industrial, Forensic and Systems and more…
Manufacturing: Lean Manufacturing, Packaging, Process, Safety & OSHA, Supply Chain, Product Design & Development and more…
Litigation: Expert Witnesses, Product Liability, Patent & Trademark Infringement, Personal Injury, Trade Secret, Construction, Damages & Valuations, and more…
Materials: Metallurgy, Chemical Engineering, Process Engineering and more…
Life Sciences: Medical & Medical Devices, Pathology, Toxicology, Microbiology and more…
Safety & Accident Investigation
Technical Due Diligence
Failure Analysis
Insurance
 
Expert Consulting Services
As soon as you contact us, we’ll assemble a team that can quickly and effectively find ways to optimize the quality and productivity of your manufacturing process. Along the way, our experts will show you how to minimize risks and hazards while maximizing profitability. From assembly and cost reduction to planning and audits, we’ll help you find ways to improve your operation. In the end, it means the only expensive choice is not calling us.

Learn concepts and evaluations include
Manufacturing Process Development . Analysis . Selection . Prototype . Validation
Manufacturing Process Development
Process development
Process within the medical device manufacturing area such as assembly, inspection, testing, receiving, fabrication, sterilization, packaging, and others all require a careful process development method. Toltec provides services to help your company development processes that are effective and compliant from regulatory perspective.
Process Analysis
An element required for building effective processes is process analysis. Two widely used analysis tools are 1) process fmeas and 2) statistical analysis. Toltec provides engineers with deep experience with these and other process analysis techniques.
Manufacturing Process Selection
Injection molding
Thermoforming
Structural foam
Composites
Machining
Sheet metal
Ceramics
Coatings
Fastening techniques
Assembly
Test
Process validation
Protocol development
I.Q. (Installation Qualification)
O.Q. (Operational Qualification)
P.Q. (Performance Qualification)
Product vs. process considerations
Prior to product release, manufacturing process needs validation
Typical processes are assembly and test
Some elements of design verification can be used for process validation, but typically there are differences:
Design verification is used to release designs (drawings)
Process validation is used to release processes (assemblies, tests)
Medical Device Design Engineering Consulting Programs
Our expert can help companies in all phases of a project with specific programs tailored to your immediate needs and requirements.
Program Management • Quality Programs • Project Assessments
Specific Programs
Independent Project Assessment
Planning and Strategy for International Projects
Independent Assessment of Project Software Aspects
Corrective Action Techniques for Software Projects
Safety Design Strategy (e.g. Medical Devices)
Systems Engineering Strategy
Onsite Instruction for Compliant Medical Device Development
Independent Decision Recommendations for Projects Examples: Major Project Decisions, including Reorganization, Safety Rationale/Analysis (e.g. Medical Devices), Selection of Software Operating Systems, Software Development Environment, Project/Development Tools, Project Standards, Selection of Specific Components
Our Programs Share the Following Characteristics
We utilize state of the art industry recognized techniques
Standards are employed whenever possible
Programs are conducted by personnel with hands-on experience
We will customize the program for your specific need
Review of Planned Project Process
Status vs. Plan
Review of Project in terms of managing the following:
Particular Considerations for International Aspects (if applicable)
Recommendations