Jose Ayala
Global Quality & Regulatory Executive | 41 Yrs MedTech | FDA, EU MDR, ISO | 130+ Class II/III Approvals |...
A distinguished Global Quality & Regulatory Executive with over 41 years of extensive experience in the MedTech industry, specializing in FDA, EU MDR, and ISO standards. Proven expertise in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class II/III approvals. Adept at architecting post-market surveillance and compliance strategies, building audit-ready QMS, and leading cross-functional teams to accelerate global market access. A trusted Subject Matter Expert (SME) in MedTech investment risk and regulatory due diligence, empowering investors and startups to successfully navigate high-stakes global regulations. Passionate about fostering a culture of quality and regulatory excellence to achieve business growth and profitability. Holds a Master of Science in Clinical Nutrition and a Bachelor of Science in Biology, providing a unique interdisciplinary perspective.
About
A distinguished Global Quality & Regulatory Executive with over 41 years of extensive experience in the MedTech industry, specializing in FDA, EU MDR, and ISO standards. Proven expertise in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class II/III approvals. Adept at architecting post-market surveillance and compliance strategies, building audit-ready QMS, and leading cross-functional teams to accelerate global market access. A trusted Subject Matter Expert (SME) in MedTech investment risk and regulatory due diligence, empowering investors and startups to successfully navigate high-stakes global regulations. Passionate about fostering a culture of quality and regulatory excellence to achieve business growth and profitability. Holds a Master of Science in Clinical Nutrition and a Bachelor of Science in Biology, providing a unique interdisciplinary perspective.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 41
- **510(k)s submitted (self-reported):** 5
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, APAC, LATAM, MEA
- **Client types:** startup, sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
- **Certifications:** Artificial Intelligence Consultant Certification
### **Cruxi analysis**
- **Strength summary:** With 41 years of experience in the medtech industry, this consultant specializes in providing comprehensive regulatory expertise, particularly in FDA compliance, EU MDR, and ISO standards. Their extensive experience in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class II/III approvals, demonstrates their ability to navigate complex regulatory landscapes. Their expertise in architecting post-market surveillance and compliance strategies, building audit-ready QMS, and leading cross-functional teams to accelerate global market access showcases their value in ensuring regulatory readiness. Additionally, their proficiency in managing QMS modernization, digital transformation projects, and conducting rigorous audits further establishes their reputation as a trusted regulatory professional. Furthermore, their experience as a trusted Subject Matter Expert (SME) in MedTech investment risk and regulatory due diligence highlights their ability to empower investors and startups to successfully navigate high-stakes global regulations.
- **Unique value:** This consultant stands out due to their unique combination of FDA experience, device expertise, regulatory depth, and track record of success in navigating complex regulatory landscapes. Their ability to architect post-market surveillance and compliance strategies, build audit-ready QMS, and lead cross-functional teams to accelerate global market access sets them apart from other regulatory professionals. Their deep expertise in key regulatory standards, including FDA, EU MDR, ISO 13485, and ISO 14971, further solidifies their position as a trusted advisor for medtech companies seeking regulatory excellence.
- **Ideal projects:** This consultant is best suited for medtech companies that require expertise in Ophthalmic, CRM, and combination products, particularly those seeking to navigate complex regulatory pathways such as FDA, EU MDR, and international submissions. Ideal projects would involve first submissions, complex devices, international expansion, or post-market surveillance and compliance strategies. Startups, SMEs, and large medtech companies with a need for accelerated global market access and regulatory readiness would benefit from engaging this consultant. Their unique combination of regulatory expertise, device knowledge, and technical skills makes them an ideal choice for companies seeking to ensure sustained market compliance and successful product launches.
- **Confidence score:** 100/100
- **Last analyzed:** Sat Dec 20 2025 01:18:23 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** pma, international
- **Device classes:** class-ii, class-iii
- **Specialties:** ophthalmic, cardiovascular, software-samd, regulatory strategy, risk management, quality system implementation, quality management systems
- **Device panels:** ophthalmic, cardiovascular
- **Regulatory pathways:** 510k, pma, post_market
- **Type:** independent
- **Years of experience:** 41
- **510(k)s submitted (self-reported):** 5
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, APAC, LATAM, MEA
- **Client types:** startup, sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
- **Certifications:** Artificial Intelligence Consultant Certification
### **Cruxi analysis**
- **Strength summary:** With 41 years of experience in the medtech industry, this consultant specializes in providing comprehensive regulatory expertise, particularly in FDA compliance, EU MDR, and ISO standards. Their extensive experience in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class II/III approvals, demonstrates their ability to navigate complex regulatory landscapes. Their expertise in architecting post-market surveillance and compliance strategies, building audit-ready QMS, and leading cross-functional teams to accelerate global market access showcases their value in ensuring regulatory readiness. Additionally, their proficiency in managing QMS modernization, digital transformation projects, and conducting rigorous audits further establishes their reputation as a trusted regulatory professional. Furthermore, their experience as a trusted Subject Matter Expert (SME) in MedTech investment risk and regulatory due diligence highlights their ability to empower investors and startups to successfully navigate high-stakes global regulations.
- **Unique value:** This consultant stands out due to their unique combination of FDA experience, device expertise, regulatory depth, and track record of success in navigating complex regulatory landscapes. Their ability to architect post-market surveillance and compliance strategies, build audit-ready QMS, and lead cross-functional teams to accelerate global market access sets them apart from other regulatory professionals. Their deep expertise in key regulatory standards, including FDA, EU MDR, ISO 13485, and ISO 14971, further solidifies their position as a trusted advisor for medtech companies seeking regulatory excellence.
- **Ideal projects:** This consultant is best suited for medtech companies that require expertise in Ophthalmic, CRM, and combination products, particularly those seeking to navigate complex regulatory pathways such as FDA, EU MDR, and international submissions. Ideal projects would involve first submissions, complex devices, international expansion, or post-market surveillance and compliance strategies. Startups, SMEs, and large medtech companies with a need for accelerated global market access and regulatory readiness would benefit from engaging this consultant. Their unique combination of regulatory expertise, device knowledge, and technical skills makes them an ideal choice for companies seeking to ensure sustained market compliance and successful product launches.
- **Confidence score:** 100/100
- **Last analyzed:** Sat Dec 20 2025 01:18:23 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** pma, international
- **Device classes:** class-ii, class-iii
- **Specialties:** ophthalmic, cardiovascular, software-samd, regulatory strategy, risk management, quality system implementation, quality management systems
- **Device panels:** ophthalmic, cardiovascular
- **Regulatory pathways:** 510k, pma, post_market
Key Highlights
- With 41 years of experience in the medtech industry, this consultant specializes in providing comprehensive regulatory expertise, particularly in FDA compliance, EU MDR, and ISO standards. Their extensive experience in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class II/III approvals, demonstrates their ability to navigate complex regulatory landscapes. Their expertise in architecting post-market surveillance and compliance strategies
- This consultant stands out due to their unique combination of FDA experience, device expertise, regulatory depth, and track record of success in navigating complex regulatory landscapes. Their ability to architect post-market surveillance and compliance strategies, build audit-ready QMS, and lead cross-functional teams to accelerate global market access sets them apart from other regulatory professionals. Their deep expertise in key regulatory standards, including FDA, EU MDR, ISO 13485, and ISO
Certifications & Trust Signals
- 41 years experience
- 5 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- This consultant is best suited for medtech companies that require expertise in Ophthalmic, CRM, and combination products, particularly those seeking to navigate complex regulatory pathways such as FDA, EU MDR, and international submissions. Ideal projects would involve first submissions, complex devices, international expansion, or post-market surveillance and compliance strategies. Startups, SMEs
HQ:
United States
Languages:
English
Status:
listed
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:
PMA
Device Types Supported:
SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
41
Num510k Submitted:
5
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ophthalmic, cardiovascular
Technology Types:
samd, ai_ml, combo_product
Accepting New Clients:
No
