Consulting services for Small Business Medical Device companies; specializing in US FDA compliance cGMP, CAPA, (510(k)’s, PMA’s, IDE’s, 513(g) submissions), Health Canada, CFDA, KFDA, EU MDD 93/42/EEC, ISO9001, ISO13485
Technical writing: Custom quality manuals, standard operating, and business procedures experience. Senior Auditor: FDA, OSHA, and EPA regulations. Design, prototype, and limited manufacture of custom electronic devices, for medical industry investigative studies. Acting QA & Regulatory Affairs Director for several medical device manufacturing companies. Medical Device Design, Food and Drug Device Approval, and all documentation related to these activities.
Client countries; United States, Canada, UK, South Korea, China, Czech Republic, Italy, and Poland.
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