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.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
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
Supports Estar:
Yes
Provides Submission Project Management:
Yes
