United Healthcare
Phone: (714) 364-5229
Email:
   
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REGULATORY SERVICES
United Healthcare Inc.(UHC) provides a broad range of regulatory, engineering, and quality assurance consulting services, clinical trial services, and regulatory department training services to meet your needs. Although we focus on cardiovascular and general hospital devices, our education, experience, and broad knowledge of FDA's processes and requirements have proven valuable for manufacturers of medical devices intended for various medical specialty areas. Whether large or small, numerous companies have found our services invaluable to their medical device development and regulatory strategy processes.
UHC medical device engineering services compliant with US FDA and international regulatory standards. We assist medical device companies with the development and maintainence of medical devices in full compliance with the regulations and standards.
We have the capability to provide full R&D medical device engineering services or can supplement medical device companies’ internal needs throughout the product life-cycle.
Leveraging the quality and experience of UHC Inc., engineers enables medical device companies to realize new and/or re-engineered devices in the market at a lower overall cost.
We offer:
Design records and validations
Formal classification reports
Detailed risk management studies to EN ISO 14971
Clinical efficacy and safety reports to Guidance MEDDEV 2.7.1: rev 3, December 2009 Clinical evaluation: A guide for manufacturers and notified bodies
Essential requirement check lists including specialty reviews of for electrical device safety to EN ISO 60601-1 3rd edition based on previous testing
Preparation of Declarations of Conformity
Approvals of labels and instruction sheets including 3rd party checked medical translations
Own-branding from 3rd party manufacturers
Product registration
Monthly regulatory updates
US FDA registrations and submissions
Consulting Capabilities
United Healthcare offers consulting services in product development, project planning, process development, sterilization, and packaging of biological.
We have proven experience in:
Vascular Implants
Endovascular Stent Grafts
Peripheral Stents and Stent Grafts
Artificial Heart and LVAD Systems and Controllers
Heart Valves
Venous Valves
Nitinol Devices
Extracorporeal Filters and Oxygenators
Medical Textiles
Catheters and Leads
RF Energy Systems
Biomaterials
Explant Analysis
ePTFE Technology

Medical Device Risk Analysis

UHC offers a complete range of risk analysis services. To gain a complete perspective of risk related to your medical device, we recommends in the following ways:
Hazard Identification
UHC has experience with many types of medical devices and can assist you in understanding what hazards may exist. Examples of hazards from other medical devices:
Electric Shock
Hemolysis
Chemical poisoning
Mechanical hazards
Hypothermia
Fire
Etc. (UHC has seen many other types hazards from a broad range of medical devices)
 
 
Analysis
Provide mechanisms and definitions for Severity and Probability of occurrence
Provide a risk mitigation strategy
Provide an independent review of your existing analysis 

Medical Device Validation and Verification

United Healthcare offers a wide range of independent validation and verification services to help you meet that challenge of complying with FDA's QSR and ISO's 13485 quality system directives. According to the FDA QSR, CE validation is the "confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled." Verification is "confirmation by examination and provision of objective evidence that specified requirements have been fulfilled." The following are validation and verification services we provide:
 
Validation and Verification
Planning
System level
Software
Mechanical
Electrical
Process validation
Field and/or clinical level