James Barley Email & Phone Number

Provide Regualtory and Quality Assurance consulting services to small and medium sized companies. Set-up and implement quality systems compliant to the FDA's 21 CFR Part 820, 21 CFR Part 110 and 111, ISO 13485 and ISO 9001. Conduct internal audits for compliance to quality system and assistance with FDA compliance audits.Provide outsourcing opportunities for US Companies. Affiliated with a number of Chineese manufacturers who have extensive experience manufacturing medical devices for major US Companies. In addition, can provide sources for new products from international manufacturers. Assistance with developing Design History Files and Technical Files for the CE Mark including Risk Analysis. Develop the protocols, assist with testing and inspections and write Final Reports for Molding, Packaging, Sterilization and Software Validations.Prepare and submit 510(k)'s, Pre-Market Approval Applications and Investigational Device Exemptions (IDE's).

Southern California

Provide Regualtory and Quality Assurance consulting services to small and medium sized companies. Set-up and implement quality systems compliant to the FDA's Quality System Regulation, ISO 13485 and ISO 9001. Conduct internal audits for compliance to quality system and assistance with FDA compliance audits.Assistance with developing Design History Files and Technical Files for the CE Mark including Risk Analysis. Develop the protocols, assist with testing and inspections and write Final Reports for Molding, Packaging, Sterilization and Software Validations.Prepare and submit 510(k)'s, Pre-Market Approval Applications and Investigational Device Exemptions (IDE's).

Duluth, Ga

Set up and implemented a quality system compliant with the FDA's Quality System Regulation and ISO 13485:2003. As Management Representative, responsibilities include maintenance of the QMS and Device Master Records for lnviro Medical Devices. Conduct site audits and product inspections in Hungary, China, Korea, Taiwan and Korea. Assisted manufacturers in developing incoming, in-process and final inspection criteria and techniques. Submitted 510(k)'s for safety syringes and needles.

This product is for the injection of medicines and vaccines without a needle. The medication is drawn into an Ampule which includes an Ampule Body and Plunger/Plunger Tip. The Ampule is then screwed into the end of the cocked injector and placed against the user's shin. The trigger is pushed and a high powered spring provides the force to inject the medication into the body without a needle. Filed 510(k)'s Jet Injectors.

These generic Reservoirs/syringes and infusion sets are compatible with MiniMed infusion pumps for diabetics. The Reservoirs consist of a Barrel and Plunger/Plunger Tip. The users fills the reservoir with insulin, attaches the infusion set and places the reservoir in the infusion pump. The pump then dispenses the medication to the user.

Greater San Diego Area

Worked with the company's R&D Department in the development of Hemodynamics monitoring devices. Filed multiple 510(k)'s on the device. The device consisted of proprietary hardware and software development, integration into existing over the counter hardware and software and electrodes for monitoring patient parameters. The 510(k) consisted of hardware and software validations.

Pasadena, Ca

Worked with the company's R&D Department to develop a glucometer using a proprietary membrane to measure the patient's blood sugar level. Developed all verification and validation test protocols and participated in all bench testing which included blood glucose testing and interference testing. Wrote the clinical study protocols, set up and trained the clinical sites, monitored the clinical study and wrote the final report which included a summary of all clinical data. Filed and received marketing clearance from the FDA for the device.

Responsible for the day to day operation of the company including manufacturing, production control, quality assurance, R&D, Finance and administration of this start up company. Reported to the Board of Directors. Developed the protocol, set-up and monitored the 500 subject clinical trial for the Class III device. In addition, participated in the development of the final report. In addition, submitted the Investigational Device Exemption, Annual Reports, Supplemental Report and Pre-Market-Approval Application for the intraocular lenses.

Mba, Marketing

Bs, Engineering

Education record

Internal Auditor Course, BSI training Services Introduction to European Medical Directives Conducting Successful Clinical Trials Under GCP.