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: 

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  • Alpha Therapeutic Corporation
  • Medtronic Cardiopulmunary
  • Sorin Biomedical
  • Gensci OrthoBio. (Integra)
  • SynCardia, Inc.
  • General Electric-Amersham, Labs
  • Mallinckrodt Medical
  • QLT Photo therapeutics
  • SSL Intl. (Reckitt Benckiser)
  • Edwards Lifesciences Inc.

JD Consulting Major Accomplishments:

Manufacturing Problem Solving

  • 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.

Quality/Regulatory Medical Manufacturing Solutions

  • 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

Medical Manufacturing Product Development

  • 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

Get Medical Manufacturing or Quality/Regulatory Solutions Now! Call Us Today 949-701-0214

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