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JD Consulting
1 Sunshine
Irvine, CA 92603
Tel: 949/854-4534
Fax: 949/854-2672
Contact: Jack Dhuwalia
Year Established: 1992
No. of Employees: 2
Key Clients: Biosensors International, Edwards LifeSciences, Alpha Therapeutics, Nycomed-Amersham, World Minerals, Medtronic, Mallinckrodt, Sorin Biomedical.
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 Consultants Directory on Medical Device Link:
- Audits/Inspections (38 companies)
- Engineering (33 companies)
- Failure Analysis (14 companies)
- Good Manufacturing Practices/Compliance (51 companies)
- Insurance/Risk Management (2 companies)
- ISO 9000 (18 companies)
- Lean Processes (1 companies)
- Manufacturing (13 companies)
- Materials Selection (11 companies)
- Molding (3 companies)
- Packaging (12 companies)
- Process Validation (32 companies)
- Product Development (44 companies)
- Product Liability (4 companies)
- Project Management (25 companies)
- Quality Assurance (44 companies)
- Regulatory Affairs (49 companies)
- Reliability Engineering (6 companies)
- Research & Development (31 companies)
- Six Sigma (1 companies)
- Sterilization (15 companies)
- Technology Transfer (5 companies)
- Training (32 companies)
- Vendor Sourcing (10 companies)
