FDA Consulting, LLC can assist you with a wide range of US domestic and international regulatory affairs and quality system requirements.
We maintain effective working relationships with managers and reviewers in multiple Divisions within the Center for Devices and Radiological Health (CDRH) in FDA.
We partner with a number of industry experts on product-specific requirements, including product safety engineering to IEC standards, sterilization validation, biocompatibility testing, packaging validation, FDA and IEC laser safety regulations, and software validation.
United States Domestic Regulatory and Quality Systems Compliance