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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 2
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** sme, large_medtech
- **Location:** Italy
- **Availability:** available_now
- **Certifications:** ICH Good Clinical Practice E6(R3), Data and Sample Governance for Biomedical Research, Introduction to Infectious Disease Preparedness micro learning, Certificate of Completion – Drug Development
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### **Cruxi analysis**
- **Strength summary:** Joel Akoto brings a powerful combination of a strong pharmaceutical academic background and hands-on regulatory experience from a global leader, Johnson & Johnson Medtech. With 2 years of focused experience, he possesses highly current and practical expertise in the complex EU MDR and IVDR frameworks, a critical need for any company operating in Europe. His proven skills in compiling technical files, managing post-market surveillance, and supporting clinical trial compliance (GCP, ISO 14155) demonstrate his ability to manage the product lifecycle effectively. This unique blend of big medtech experience and up-to-date knowledge of EU/FDA regulations makes him an exceptionally valuable asset for companies needing to ensure compliance for IVDs, medical devices, and combination products.
- **Unique value:** Joel Akoto's key differentiator is the fusion of his deep scientific understanding of drug development with practical, real-world regulatory experience gained within a top-tier global medtech company. This dual perspective provides a holistic view of the product lifecycle, making him uniquely equipped to handle the nuanced challenges of combination products and to build comprehensive regulatory strategies that bridge scientific rationale with compliance requirements for both EU and US markets.
- **Ideal projects:** The ideal client for Joel is a small-to-medium-sized enterprise (SME) or a large medtech company seeking to navigate the European regulatory landscape or manage post-market obligations. He is perfectly suited for projects involving Class I or Class II IVDs and medical devices, particularly combination products that benefit from his dual pharma and device expertise. Companies would engage him for critical projects such as achieving CE marking under MDR/IVDR, developing robust technical files, establishing ISO 13485 compliant QMS, or managing post-market surveillance and clinical follow-up (PMS/PMCF). His bicultural EU/US knowledge also makes him an excellent resource for American firms expanding into Europe or vice versa.
- **Last analyzed:** Thu Dec 25 2025 15:34:11 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** clinical-trials, qms, international
- **Device classes:** class-i, class-ii
- **Specialties:** ivd, general-hospital, other
- **Device panels:** ivd
- **Regulatory pathways:** ide, post_market
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- **Type:** independent
- **Years of experience:** 2
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** sme, large_medtech
- **Location:** Italy
- **Availability:** available_now
- **Certifications:** ICH Good Clinical Practice E6(R3), Data and Sample Governance for Biomedical Research, Introduction to Infectious Disease Preparedness micro learning, Certificate of Completion – Drug Development
---
### **Cruxi analysis**
- **Strength summary:** Joel Akoto brings a powerful combination of a strong pharmaceutical academic background and hands-on regulatory experience from a global leader, Johnson & Johnson Medtech. With 2 years of focused experience, he possesses highly current and practical expertise in the complex EU MDR and IVDR frameworks, a critical need for any company operating in Europe. His proven skills in compiling technical files, managing post-market surveillance, and supporting clinical trial compliance (GCP, ISO 14155) demonstrate his ability to manage the product lifecycle effectively. This unique blend of big medtech experience and up-to-date knowledge of EU/FDA regulations makes him an exceptionally valuable asset for companies needing to ensure compliance for IVDs, medical devices, and combination products.
- **Unique value:** Joel Akoto's key differentiator is the fusion of his deep scientific understanding of drug development with practical, real-world regulatory experience gained within a top-tier global medtech company. This dual perspective provides a holistic view of the product lifecycle, making him uniquely equipped to handle the nuanced challenges of combination products and to build comprehensive regulatory strategies that bridge scientific rationale with compliance requirements for both EU and US markets.
- **Ideal projects:** The ideal client for Joel is a small-to-medium-sized enterprise (SME) or a large medtech company seeking to navigate the European regulatory landscape or manage post-market obligations. He is perfectly suited for projects involving Class I or Class II IVDs and medical devices, particularly combination products that benefit from his dual pharma and device expertise. Companies would engage him for critical projects such as achieving CE marking under MDR/IVDR, developing robust technical files, establishing ISO 13485 compliant QMS, or managing post-market surveillance and clinical follow-up (PMS/PMCF). His bicultural EU/US knowledge also makes him an excellent resource for American firms expanding into Europe or vice versa.
- **Last analyzed:** Thu Dec 25 2025 15:34:11 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** clinical-trials, qms, international
- **Device classes:** class-i, class-ii
- **Specialties:** ivd, general-hospital, other
- **Device panels:** ivd
- **Regulatory pathways:** ide, post_market
---
Key Highlights
- Joel Akoto brings a powerful combination of a strong pharmaceutical academic background and hands-on regulatory experience from a global leader, Johnson & Johnson Medtech. With 2 years of focused experience, he possesses highly current and practical expertise in the complex EU MDR and IVDR frameworks, a critical need for any company operating in Europe. His proven skills in compiling technical files, managing post-market surveillance, and supporting clinical trial compliance (GCP, ISO 14155) dem
- Joel Akoto's key differentiator is the fusion of his deep scientific understanding of drug development with practical, real-world regulatory experience gained within a top-tier global medtech company. This dual perspective provides a holistic view of the product lifecycle, making him uniquely equipped to handle the nuanced challenges of combination products and to build comprehensive regulatory strategies that bridge scientific rationale with compliance requirements for both EU and US markets.
Certifications & Trust Signals
- 2 years experience
Buyer Snapshot
Best for
- The ideal client for Joel is a small-to-medium-sized enterprise (SME) or a large medtech company seeking to navigate the European regulatory landscape or manage post-market obligations. He is perfectly suited for projects involving Class I or Class II IVDs and medical devices, particularly combination products that benefit from his dual pharma and device expertise. Companies would engage him for c
HQ:
Italy
Languages:
English, Italian
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
