Services

Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:

Regulatory Submissions

• FDA Establishment Registration and Listing
• US Agent for Foreign Manufacturers
• Premarket Notification 510(k)
• Investigational Device Exemptions (IDE)
• Premarket Approval Submissions (PMA)
• Technical File/Design Dossier for CE Marking (MDD and IVDD)
• Health Canada Licenses
• Foreign country regulatory submission

FDA and ISO Quality Systems Requirements

• Quality system audit
• Quality procedure review and gap assessments
• Labeling review and gap assessments
• Design control protocols and report

Other

We have direct experience working with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations. Visit the Links page to access the services of our recommended colleagues.