Diego Rua
Ph.D. Scientific & Regulatory Consultant | Biomedical Expertise | Big Data Analysis | FDA Regulatory Affairs
An accomplished scientific consultant with a Ph.D. in Molecular & Cellular Biology and an M.B.A. with a concentration in Strategic Management. He boasts over 26 years of experience in biomedicine and big data analysis, with expertise in performing safety and toxicological assessments, reviewing pre-clinical and clinical studies, and evaluating post-market surveillance data for FDA-regulated products.
About
An accomplished scientific consultant with a Ph.D. in Molecular & Cellular Biology and an M.B.A. with a concentration in Strategic Management. He boasts over 26 years of experience in biomedicine and big data analysis, with expertise in performing safety and toxicological assessments, reviewing pre-clinical and clinical studies, and evaluating post-market surveillance data for FDA-regulated products.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 26
- **510(k)s submitted (self-reported):** 50
- **Ex-FDA:** Yes
- **Ex-Big MedTech:** Yes
- **Regions served:** US
- **Client types:** startup, sme
- **Location:** United States (Maryland)
- **Availability:** available_now
- **Certifications:** Google Data Analytics Professional Certificate, Reviewer Certification Program, Contracting Officer Technical Representative (COTR) certification
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### **Cruxi analysis**
- **Strength summary:** Dr. Diego Rua represents a rare fusion of deep scientific expertise, strategic business acumen, and invaluable regulatory insight gained from his tenure as a former FDA CDRH/CDER reviewer. With 26 years of experience, a Ph.D. in Molecular & Cellular Biology, and an MBA, he provides a uniquely holistic approach to regulatory consulting. His direct experience evaluating biocompatibility, pre-clinical/clinical studies, and post-market data from inside the FDA gives medtech companies a critical advantage in developing robust, reviewer-friendly submissions. Complemented by a proven track record of 50+ 510(k)s, 10 De Novos, and 5 PMAs, alongside modern big data analysis skills, Dr. Rua is exceptionally equipped to de-risk complex regulatory pathways for novel medical technologies.
- **Unique value:** Dr. Rua's standout value lies in his powerful combination of being an ex-FDA reviewer, a Ph.D. scientist, and an MBA strategist. This trifecta allows him to dissect complex scientific data, anticipate regulatory scrutiny with an insider's perspective, and align the submission strategy with core business objectives. For medtech companies, this translates into a more efficient, de-risked path to market authorization, guided by a consultant who understands the science, the regulation, and the business of innovation.
- **Ideal projects:** The ideal client for Dr. Rua is a startup or SME developing an innovative device in the cardiovascular, orthopedic, IVD, or wearable technology sectors. This company would likely be navigating a complex regulatory pathway such as a De Novo, PMA, or a challenging 510(k) for the first time, requiring a comprehensive strategy from classification and testing to final submission. Dr. Rua's expertise is best leveraged early in the development process, particularly for crafting Q-Submission strategies and designing effective pre-clinical test plans. Companies with devices that have challenging biocompatibility, toxicological, or data analysis components will find his deep scientific and FDA reviewer background particularly beneficial for achieving regulatory success.
- **Last analyzed:** Tue Jan 06 2026 10:16:51 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma
- **Device classes:** class-ii
- **Specialties:** other, cardiovascular, orthopedic, dental, ivd, general-hospital
- **Device panels:** general_surgery, dental, ivd, wearable_digital, cardiovascular, orthopedic
- **Regulatory pathways:** 510k, pma, de_novo, q_sub, ide
---
- **Type:** independent
- **Years of experience:** 26
- **510(k)s submitted (self-reported):** 50
- **Ex-FDA:** Yes
- **Ex-Big MedTech:** Yes
- **Regions served:** US
- **Client types:** startup, sme
- **Location:** United States (Maryland)
- **Availability:** available_now
- **Certifications:** Google Data Analytics Professional Certificate, Reviewer Certification Program, Contracting Officer Technical Representative (COTR) certification
---
### **Cruxi analysis**
- **Strength summary:** Dr. Diego Rua represents a rare fusion of deep scientific expertise, strategic business acumen, and invaluable regulatory insight gained from his tenure as a former FDA CDRH/CDER reviewer. With 26 years of experience, a Ph.D. in Molecular & Cellular Biology, and an MBA, he provides a uniquely holistic approach to regulatory consulting. His direct experience evaluating biocompatibility, pre-clinical/clinical studies, and post-market data from inside the FDA gives medtech companies a critical advantage in developing robust, reviewer-friendly submissions. Complemented by a proven track record of 50+ 510(k)s, 10 De Novos, and 5 PMAs, alongside modern big data analysis skills, Dr. Rua is exceptionally equipped to de-risk complex regulatory pathways for novel medical technologies.
- **Unique value:** Dr. Rua's standout value lies in his powerful combination of being an ex-FDA reviewer, a Ph.D. scientist, and an MBA strategist. This trifecta allows him to dissect complex scientific data, anticipate regulatory scrutiny with an insider's perspective, and align the submission strategy with core business objectives. For medtech companies, this translates into a more efficient, de-risked path to market authorization, guided by a consultant who understands the science, the regulation, and the business of innovation.
- **Ideal projects:** The ideal client for Dr. Rua is a startup or SME developing an innovative device in the cardiovascular, orthopedic, IVD, or wearable technology sectors. This company would likely be navigating a complex regulatory pathway such as a De Novo, PMA, or a challenging 510(k) for the first time, requiring a comprehensive strategy from classification and testing to final submission. Dr. Rua's expertise is best leveraged early in the development process, particularly for crafting Q-Submission strategies and designing effective pre-clinical test plans. Companies with devices that have challenging biocompatibility, toxicological, or data analysis components will find his deep scientific and FDA reviewer background particularly beneficial for achieving regulatory success.
- **Last analyzed:** Tue Jan 06 2026 10:16:51 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma
- **Device classes:** class-ii
- **Specialties:** other, cardiovascular, orthopedic, dental, ivd, general-hospital
- **Device panels:** general_surgery, dental, ivd, wearable_digital, cardiovascular, orthopedic
- **Regulatory pathways:** 510k, pma, de_novo, q_sub, ide
---
Key Highlights
- Dr. Diego Rua represents a rare fusion of deep scientific expertise, strategic business acumen, and invaluable regulatory insight gained from his tenure as a former FDA CDRH/CDER reviewer. With 26 years of experience, a Ph.D. in Molecular & Cellular Biology, and an MBA, he provides a uniquely holistic approach to regulatory consulting. His direct experience evaluating biocompatibility, pre-clinical/clinical studies, and post-market data from inside the FDA gives medtech companies a critical adva
- Dr. Rua's standout value lies in his powerful combination of being an ex-FDA reviewer, a Ph.D. scientist, and an MBA strategist. This trifecta allows him to dissect complex scientific data, anticipate regulatory scrutiny with an insider's perspective, and align the submission strategy with core business objectives. For medtech companies, this translates into a more efficient, de-risked path to market authorization, guided by a consultant who understands the science, the regulation, and the busin
Certifications & Trust Signals
- 26 years experience
- 50 510(k)s submitted (self-reported)
- Ex-FDA
Buyer Snapshot
Best for
- The ideal client for Dr. Rua is a startup or SME developing an innovative device in the cardiovascular, orthopedic, IVD, or wearable technology sectors. This company would likely be navigating a complex regulatory pathway such as a De Novo, PMA, or a challenging 510(k) for the first time, requiring a comprehensive strategy from classification and testing to final submission. Dr. Rua's expertise is
HQ:
United States
Languages:
English
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
26
Num510k Submitted:
50
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
general_surgery, dental, ivd, wearable_digital, cardiovascular, orthopedic
Technology Types:
ivd_test, wearable_patch, implantable, combo_product
Accepting New Clients:
No
