22 weeks
FDA Medical Device Training Suite
Comprehensive training suite for medical device sales and clinical support teams meeting FDA requirements.
I ship healthcare and pharma training that holds up to FDA, OCR, and sponsor-QA review without remediation. 5+ years building HIPAA, GVP, ICH-GCP, and surgical-credentialing programs in Storyline, Veeva Vault, and Unity — including launches under PDUFA-date pressure. Every artifact arrives with a sign-off packet auditors can verify in one click.
Every case study below follows Situation · Task · Action · Result, with the design model and a live SCORM link attached.
Marcus delivered a comprehensive FDA training suite that exceeded all expectations. His understanding of regulatory requirements combined with instructional design expertise resulted in training that is both compliant and engaging.
Our HIPAA compliance scores improved dramatically after implementing Marcus's certification program. We passed our audit with zero findings related to training—first time ever. His healthcare expertise is unmatched.
Marcus rebuilt our CRA pharmacovigilance onboarding and we got back 74% of our senior PV reviewer time inside one cycle. New CRAs were processing ICSRs independently in week two — a number we'd been chasing for three years. Audit-ready, learner-respected, and shipped on the budget he scoped.
I have proctored a lot of credentialing programs. The VR rep telemetry Marcus built is the first one that actually told me where a team was weak before the live case. First-attempt pass jumped 28 points and the proctor brief landed in my hand instead of in a quarterly report.
I co-presented with Marcus at PharmaXP. What sets him apart isn't the regulatory knowledge — plenty of us have that — it's that he can defend his assessment design in a regulator meeting and a creative critique in the same week. Easiest collaborator I've had on a launch curriculum.