Accomplishments

JD Consulting has had a number of notable accomplishments in three primary areas:

• manufacturing problem solving
• quality/regulatory
• product development

Be sure to see our Services and Solutions for a listing of the specific services that we provide, our case studies to see exactly how we have helped other companies, and our testimonials to see what our clients have to say.

Manufacturing Problem Solving

• Process and product improvement of blood oxygenator and related products. Reduced manufacturing rejects by over 10%. Saved the company over $250,000/yr by reducing waste, streamlining operations, improving reliability and redesign

• Provided technical expertise in quality to save over $400,000 radio-active "seeds"

Quality/Regulatory

• Resolved quality system problems to reduce regulatory risk by 83% of a multinational client under FDA warning situation. Implemented solutions to eliminate/reduce problems

• Solved a significant quality/regulatory problem by identifying, installing and successfully starting new equipment and testing system at a multinational client under FDA warning situation

• Identified and implemented technical solutions to prevent a potential product recall of a start up company. Strengthened qualification documentation. Implemented rework procedures to save product

• Implemented design control programs and performed FMEA hazard analysis

• Over 60 qualification testing and process validation protocols and reports for extrusion, injection molding, manufacturing & packaging equipment and sterilization. Performed DOE and other engineering studies

• Conducted rapid corrective actions to bring molding operations into regulatory compliance

• Developed and implemented a custom QSR / ISO 9001 compliant design control program

• Structured and established quality systems. Prepared quality manuals and procedures to establish workable and user compatible documentation systems

• 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

• Implemented technical solutions to prevent product recall of a start up company. Strengthened qualification documentation. Implemented rework procedures to save product

• Resolved problems with sterilization and completed sterilization validations

• Conducted ISO/QSR second and third party audits for compliance to standards including ISO 9001, Directive 93/42/EEC, ISO 11135, and cGMP.

• Injection molding and other process validations including hands-on work of implementing protocol, data analysis and prepared written reports

• Implemented package/product design qualifications and design control

Product Development

• Manufacturing technology transfer of an embolectomy catheter to Singapore. Implemented all aspects including process and sterilization validation

• Designed and developed an introducer system for laser fibers in transurethral treatment. Worked with leading Urologists from USA, Canada and Germany

• Qualification/validation including design, development and 510(k) preparation for a phonation valve

• Worked with client and subcontractors in development thru regulatory approval of laser fiber optic device for photodynamic therapy for treatment of esophageal cancer