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Regulatory

510K Notifications

Quality Systems

Manufacturing Assistance

Our services include:

• US Agent representation for non-US medical device manufacturers as required by FDA regulations.

• Regulatory strategic planning, compliance issues including resolution of FDA 483 and warning letters, import and export problem solving.

• Submitting 510K notifications to clear products into the US market.

• Developing, implementing and maintaining quality systems that will achieve certifications to ISO 9001 and ISO 13485

• Developing technical files that will allow for CE marking the products.

• Internal auditing, process validations including statistical process control (SPC), manufacturing protocols including sterilization, and software validations.

• Manufacturing Assistance services

Mansour Consulting LLC prides itself to be a one-stop-shop in Quality and Regulatory for medical devices.

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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