> Regulatory Affairs Strategy Development
> FDA Submissions:
510(k)s
Investigational Device Exemptions
(IDEs)
Pre-Market Approval (PMA)
>
FDA Registered U.S. Agent for Foreign Manufacturers
>
Training Programs/Seminars/Distance
Education
> Due Diligence
> HIPAA & CFR 21 Part 11
Compliance
> Quality Systems Compliance (QSRs,
QA/QC, GMPs, SOPs)
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