About JD Consulting

JD Consulting was co-founded in 1992 by Jack Dhuwalia and Jayne Shinoda.

We have had the privilege of working with many top-tier Medical Manufacturers, including those below:

about_jd_consulting

JD Consulting Major Accomplishments:

Process/product improvement of blood oxygenator and related products. Reduced manufacturing rejects by over 10%. Saved company over $250K/yr. by reducing waste, streamlining operations, improving reliability/redesign
Solved a significant quality/regulatory problem for brachytherapy – saving over $400K/yr.

Prepared a Class II device company in India for FDA QSIT inspection
Reduced regulatory risk by 83% of a multinational client for brachytherapy
Solved a quality/regulatory problem by implementing a new sterile packaging system at a multinational client under FDA warning letter situation
Implemented technical solutions to prevent a potential product recall for a start-up
Implemented design control programs and performed FMEA hazard analysis
Process validations for extrusion, injection molding, manufacturing & packaging equipment and sterilization
Conducted rapid corrective actions to bring molding operations into regulatory compliance
Implemented a custom QSR / ISO 13485 compliant design control program
Established quality systems. Prepared quality manuals and procedures
Design control administration and implementation for a multinational project
Updated GMP programs to current QSR requirements to improve compliance
Prepared 510(k) submissions
Responded to and corrected 483 problems
Resolved problems with sterilization and completed sterilization validations
Conducted ISO 13485,QSR, MDD and cGMP second and third party audits for compliance
Implemented process, package, sterilization (EtO, Gamma and e-Beam Irradiation) validations

Manufacturing technology transfer of an embolectomy catheter to Singapore
Developed an introducer system for laser fibers in transurethral treatment.
Design, development and 510(k) for a phonation valve
Worked with client and subcontractors in development through regulatory approval of laser fiber optic device for photo-dynamic therapy for treatment of esophageal cancer