Former FDA and Industry Experts Providing Pre-market, QSR and Post-market Services
Boyce Consulting provides personalized, cost-effective FDA and ISO regulatory and quality solutions and training to small and large companies, initial importers, contract sterilizers, laboratories and entrepreneurs.
Boyce Consulting has helped approximately 180 small and large companies, and entrepreneurs comply with FDA regulations, project planning, system corrective actions, 510(k) submissions, FDA strategic planning, due diligence audits, labeling reviews, process and test method validations, development and execution of risk management processes and compliance with 21 CFR 11.
Our Goal is to help you become compliant, trained, self-sufficient and consequently, self-sustaining.
We have successfully audited
we have obtained permission to market
WE HAVE DEVELOPED AND IMPLEMENTED
Medical device manufacturers, IVDs, sterilizers, laboratories and initial imports.
Medical device 510(k)s
Compliant quality systems for medical device service organizations
Ms. Boyce was one of the original instructors at the first AAMI Training on the Quality System Regulation and helped author the "AAMI Quality System Compendium GMP Requirements & Industry Practice". Ms. Boyce was one of the first consultants to develop risk-based CAPA programs to ensure compliance and efficient use of resources. Ms. Boyce has been a Special Court Master to the United States District Court of New Jersey as a regulatory and quality expert.
Ms. Boyce has served as a GMP expert for FDA and other law firms. Boyce Consulting has successfully aided national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems, and helping to solve initial importer problems. Boyce Consulting’s team includes an ex-FDA Regional Medical Device Expert as well as personnel with extensive FDA industry experience in management, risk analyses, operations, lean process design, product design and development, risk management and quality. Combined ex-FDA and industry backgrounds provides you with exceptional and uniquely-qualified consulting services.
Ms. Boyce has received:
FDA Commendable Service Awards (1990, 1991, 1992).
Nominated for FDA Investigator of the Year (1990).
Government Investigator of the Year (1990).
Selected for and completed FDA's National Mid-Level Training Program (1991-1992) during which time many assignments were completed with the FDA's Commissioner's Office; Center for Device Evaluation's Program Operations Staff; Office of Device Evaluation, Center for Devices and Radiological Health; Office of Compliance and Office of Drug Evaluation, Center for Drug Evaluation and Research; Acting Director of Compliance, FDA Kansas City District.
If you are wondering what the next step is in regaining your standing or solving any problem with the FDA, Boyce Consultants have shown our ability to work with you and your staff to resolve pressing compliance issues producing a favorable outcome. Where you may be unsure or hesitant on how best to proceed, we provide guidance based on experience.
We can help you interface with the FDA directly or we can provide effective communication and planning documentation necessary to get your firm back into full compliance.
Boyce Consulting can also help you streamline your processes using various quality methods such as process mapping to eliminate document and method redundancies, but also improving compliance.
Boyce Consulting can help you stay FDA and ISO prepared by teaching you how to sustain your quality system via an established CAPA process that requires monitoring and analyzing meaningful quality metrics that become inputs to the Management Review Process. Gap analyses and audits also help you sustain your quality system. Boyce can assist you in establishing effective gap analyses and FDA-mock audit processes.
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