Joel Akoto
Regulatory professional with expertise in EU MDR/IVDR & FDA compliance for medical devices, IVDs, and pharmaceuticals.
A bilingual Pharmacy graduate advancing his expertise with a Master's in Preclinical and Clinical Drug Development. Possesses robust knowledge of EU and FDA regulatory frameworks (MDR, IVDR, 21 CFR) for medicines, medical devices, and IVDs. Experienced in supporting international compliance activities, including CE marking, technical file compilation, post-market surveillance (PMS/PMCF), and pharmacovigilance. Proven ability to manage health data systems like EUDAMED, contribute to clinical trial oversight (GCP, ISO 14155), and collaborate with cross-functional teams at major medtech companies. Passionate about enhancing global health through regulatory harmonization and ensuring patient access to safe and effective products.
HQ:
Italy
Languages:
English, Italian
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) RTA Remediation / Refuse-to-Accept Fix
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Years Experience:
2
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd
Technology Types:
ivd_test, combo_product
Accepting New Clients:
Yes
