From concept to market
Strategic, regulatory, and operational guidance medical devices, software, and combination products, to accelerate your product's journey from concept to market.
About me
Hi! I am Albert "Skip" Farinha, the principal consultant at Strategic Regulatory Services, LLC.
I have 35 years of experience in leadership, operations, product development, regulatory and clinical affairs for Class I, II and III medical device companies, including combination devices. My careers spans Fortune 500 firms to seed-stage start-ups.
I have established systems for start-ups, including growth plans, budgets, regulatory and clinical strategy, prototype to steady-state manufacturing, and compliance for new technologies. I have submitted numerous 510Ks including initial work for de novo approvals and PMAs.
I have worked on wide range of medical technologies, including ultrasonic drug delivery, live biotherapeutic drug development, neurostimulation devices for the neonatal ICU, laparoscopic ultrasonic, and surgical lasers with disposable tools.
I have negotiated with the US FDA and German regulatory bodies, and worked with US, French, Swiss, Danish, Australian (TGA), and Italian hospital IRB committees to align regulatory strategies and clinical trial protocols for novel technologies. I have authored clinical trial and IACUC protocols, designed at-home data collection apps on smart phones.
I also have extensive experience with manual and automated manufacturing processes: machined metal, ceramics and plastics, injection molding, extrusion, deposition coatings, bacterial batch fermentation, and assembly cell manufacturing.
For investors, I can perform due diligence reviews covering technology readiness, go-to-market strategies, and regulatory risks and mitigation.
Notable past employers
Services
Business & Regulatory Strategy
Establish scalable business plans, budgets, and corporate systems for medical technology startups.
Due diligence and oversight
Due diligence reviews for investors and pre-audits (FDA, PMA). Risk analysis (FMEA, pFMEA) and ongoing compliance oversight.
Regulatory Approvals & Clearances
US FDA for 510(k) clearances, De Novo approvals, PMAs, and IDEs, and with international regulatory bodies for EU CE Mark
Manufacturing Systems Setup
Develop and optimize processes across diverse materials: machined metal, ceramics, plastics, injection molding, bacterial fermentation.
Quality Management Systems
ISO 9001/13485 registration, certification, and 21 CFR 820 QSR compliant system implementation and remediation.
Why partner with me
Direct engagement
Unlike larger firms, you will benefit from my direct, hands-on involvement, which leads to speedy decision making, clear regulatory and quality strategy, and attention to detail.
Track record
I've successfully led companies through their first FDA audits with zero observations, secured De Novo approvals, and spearheaded a successful Phase 1 clinical trial in Australia for a novel drug delivery device.
Global scope
I have a proven ability to negotiate and gain concurrence with regulatory bodies and IRB committees across the US, Europe, and Australia, facilitating global market access.
Breadth of industry knowledge
My experience spans the full spectrum of medical devices, from Class I to III, including neurostimulation, orthopedic implants, surgical lasers, robotic systems, and unique combination devices like microbial swabs with smartphone apps, and ultrasonic drug delivery.
Manufacturing knowhow
My understanding of diverse manufacturing processes—from high-volume automated lines and cleanroom operations to bacterial fermentation—ensures that we jointly develop practical, implementable solutions for your product.