JD Consulting provides expertise based on successful experience in FDA and related matters, such as Medical Quality Systems, Regulatory Compliance, Design Control and Validation, Corrective and Preventive Action (CAPA). Prompt and practical solutions to Warning letters, 483, 510k and other situations are our specialties.
Broad experience in design, manufacturing, quality and regulatory matters are applied to FDA compliance, cGMP and QSR, as well as ISO: 13485, 14971, 11135, 11137 and 11607. JD Consulting is experienced in root-cause analysis and helps our clients eliminate trial-and-error solutions for CAPA.
Some FDA compliance matters have included gap analysis and preparations for FDA QSIT inspection, as well as dealing with Warning Letter mitigation and injunction abatement.
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.
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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).
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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.
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