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Mansour Consulting LLC has been in the quality and regulatory fields for 15 years, and has successfully submitted 510k notifications to FDA with 100% acceptance rate. We have designed, implemented, and maintained numerous quality systems for our clients, and have successfully defended those systems during FDA audits. We have registered them to ISO 9001, EN 46001 and ISO 13485 and developed the technical files that allowed for CE Marking of the products.
Our clients have access to a cost-efficient network of experienced professionals in the areas of biomedical, electrical, mechanical, and manufacturing engineering as well as equipment installation, validations, and maintenance, and software validations. |
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Our consultants are members of the American Society for Quality (ASQ) and the Regulatory Affairs Professional Society (RAPS). They are certified from RAPS as RAC (Regulatory Affairs Certified) and from RAB's (Registrar Accreditation Board) as Quality Systems Auditors (ISO 9001: 1994 and ISO 9001: 2000).
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Mansour Consulting LLC - US FDA and European medical device regulatory consultants Phone: 678-908-8180, Fax: 678-623-3765, info@mansourconsulting.com |
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