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JD Consulting
1 Sunshine
Irvine, CA 92612
Tel: 888/532-4357
Fax: 949/854-2672
Web: http://www.jdconsultingsite.com
E-mail: info@jdconsultingsite.com
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JD Consulting is a technical consulting firm specializing in medical product development and regulatory compliance, solutions to manufacturing problems, improving productivity, and improving product quality of Class I, II and III medical products as well as in vitro diagnostic products (IVDs).
We’ve addressed FDA Warning Letters, upgraded the quality systems and implemented solutions accepted by the FDA. We’ve helped prepare companies resulting in satisfactory inspections by the FDA as well as by notified bodies.
Our manufacturing expertise includes process development, packaging, and sterilization validations. Our quality systems expertise includes conducting audits, design control, FMEA, risk analysis, process validations, quality engineering, and process control. We provide QSR and ISO 13485 compliance, successful 510(k) submissions to FDA, and training.
Manufacturing Problem solving
By conducting effective root cause analysis, we’ve have helped companies improve quality and lower costs. Our materials expertise includes plastics, latex, silicone and urethane. Manufacturing process, injection molding, packaging and sterilization expertise (Ethylene Oxide, Gamma irradiation, e-beam irradiation and autoclaving).
Specific service areas include:
| • Process development • Process improvement • Inspection Strategies | • Process validation • Calibration and PM • Material qualifications and management |
We can assist with ISO 13485/CE/QSR compliance including design control, Corrective and Preventive Actions, handling customer complaints, FMEA, risk mitigation, audits, validations and effective solutions to regulatory problems.
Specific service areas include:
| • QSR (quality system requirement) • Audit • Root Cause Analysis | • ISO 13485/ CE marking • 510(k) submission • Corrective and Preventive Actions |
Let JDC help you get your products off to a good start with lasting "solutions that work" so that you will be able to scale production smoothly and efficiently. Expertise includes project management and technology transfer in US, Europe and Asia.
Specific service areas include:
| • New product development • Technology transfer • Design control: QSR compliance • Packaging • Risk management | • Process development • Project management • Material qualification • Sterilization • Risk mitigation |
Categories this company is listed under in the North American Suppliers Directory:
- R&D, Design, and Business Services: Consulting/Training services (395 companies)
- R&D, Design, and Business Services: Facility design (61 companies)
- R&D, Design, and Business Services: FDA submissions (173 companies)
- R&D, Design, and Business Services: ISO 9000 certification services (77 companies)
- R&D, Design, and Business Services: Manufacturing capabilities (375 companies)
- R&D, Design, and Business Services: Process validation/QC (234 companies)
- R&D, Design, and Business Services: Product design (633 companies)
- R&D, Design, and Business Services: Product R&D (613 companies)
- R&D, Design, and Business Services: Prototyping/Rapid prototyping (475 companies)
