Your partner in compliance
Achieve software medical device regulatory compliance out in the wild west
Optimizing compliance doesn't have to come at the expense of streamlined operations.
When the going gets tough — Cowboy up!
About Cowboy Up Compliance
My Philosophy
I'm Gina Catalano, your partner in compliance since 2011.
Growing up in Salinas, California — home of THE California Rodeo — I often heard the phrase “Cowboy up!” when difficult situations required a certain attitude.
I’ve embraced this as my professional motto, and it has carried me through difficult situations as a regulatory professional at various startup companies throughout Silicon Valley. I pride myself as a corporate partner in compliance, and have more than 13 years of experience navigating the “wild west” of nascent medical device software regulation development.
To me, Cowboy up! means toughness, resilience, courage, and a willingness to face daunting challenges head-on, without backing down. It's about embodying the spirit of the rugged and stoic cowboy, and persevering through adversity with determination and grit. It's confronting obstacles, taking responsibility, and maintaining a strong and unwavering attitude, even in the face of unprecedented difficulty or hardship.
Companies I've worked at in-house:
- Big Health (digital therapeutic software for psychiatry & health/wellness products)
- PEAR Therapeutics (digital therapeutic software for psychiatry & physical health)
- iRhythm Technologies (wireless cardiac rhythm monitoring devices & diagnostic algorithms with Independent Diagnostic Testing Facility for cardiac arrhythmia analysis)
- Theranos (blood collection device manufacturer & laboratory test developer)
- Experien Group - now part of Veranex (medical device consulting firm)
My qualifications:
- Regulatory Affairs Certification - Devices (RAPS RAC-Devices)
- Regulatory Compliance Certification - Medical Device Regulation (RAPS RCC-MDR)
- Certified Software Quality Engineer (ASQ CSQE)
- Certified Medical Device Auditor (ASQ CMDA)
- Bachelor of Science degree
My Expertise
No compliance situation is too challenging for me to wrangle.
With my broad experience in medical device regulation, I can help devise compliance solutions that best fit your unique situation. Whether you're confident in your compliance posture, or if you've fallen off the horse, my independent perspective can drive value when and where it's needed most.
Where I'm versed:
- Medical devices
- In vitro diagnostics (IVDs)
- Software as/in a Medical Device (SaMD/SiMD)
- Artificial intelligence/machine learning (AI/ML) applied in health care software
- General wellness and other products/services on the border of regulation as a device
What I know:
- U.S. Laws: 21 U.S.C. 351, 352
- U.S. FDA regulations: 21 CFR Parts 7, 11, 50, 54, 56, 801, 803, 806, 807, 809, 812, 820
- EU Regulations: EU MDR 2017/745, EU IVDR 2017/746
- International standard frameworks: ISO 13485:2016, ISO 27001:2022, ISO 14971:2019, IEC 62304:2006/2015, IEC 82304-1:2016/-2:2021, IEC 62366-1:2015/-2:2016, IEC 60601-1/1-2
- Clinical: ISO 14155:2020; ICH E3, E6, E8, E9; MDCG 2020-1/MDCG 2020-6/MEDDEV 2.7/1 v.4
- Artificial Intelligence/ Machine Learning: EU Reg. COM/2021/206 (AI Act); AAMI 34971:2022, ISO/IEC 23894 (AI/ML risk management); IMDRF/AIMD WG (PD1)/N67:2021 (AI/ML guidance)
My core domains:
- Advertising, promotion & labeling
- Audits & inspections
- Clinical evaluation
- Clinical investigations
- Corporate due diligence
- Ethics
- Health Authority meetings & communication strategy
- Human factors & usability engineering
- Market authorization negotiation
- Post-market surveillance
- Product development
- Product registration
- Product recalls
- Project management
- Quality systems development
- Regulatory intelligence & policy
- Regulatory writing & documentation
- Research, design & development
- Risk management
- Total product lifecycle management
And if I'm not the guy for your job - with my wide network, it's likely I know someone who can rope it in.
My Services
I roll up my sleeves and get the job done, with no bull.
I strike a cautious balance between operational improvements and compliance burden to deliver the most business value for resources expended. I specialize in creative compliance solutions that leverage your company's good work to get you back in the saddle again.
What I can do:
Audits & inspections:
- Internal quality system audits
- Design history file audits
- Supplier audits
- FDA QSIT support (routine & for cause)
- BIMO audits
- Notified Body audits (process & product)
Clinical evaluation
- Clinical evaluation procedures
- Clinical evaluation plans
- Literature search plans
- Literature search reports
- Clinical evaluation reports
Clinical investigations
- Clinical study protocol development
- Clinical study report development
- IRB NSR study submission packages
- FDA SR IDE applications
- TMF establishment
- TMF audits
- GCP training
Enforcement actions:
- Warning Letter response strategies
- Corrective action plan development & implementation
- Field action communications
Health Authority conciliation:
- FDA 510(k) deficiency resolution
- FDA Submission Issue meeting strategy
- FDA 483 response strategy
- EU MDR/IVDR CE Mark nonconformance resolution
- IRB NSR study deficiency resolution
Product recalls & related actions:
- Health Hazard Evaluations
- Safety-related reportable recalls (FDA Class I/II)
- Internally documented recalls (FDA Class III)
- Recall management & communications
- External-facing market withdrawal activities
- Internally managed stock recovery projects
Quality systems:
- Gap analysis to standards/regulations
- Procedure development
- Procedure refinement
Regulatory documentation:
- Technological regulatory assessments
- U.S. FDA regulatory strategy
- U.S. FDA eSTAR Q-subs
- U.S. FDA eSTAR 510(k)s
- U.S. FDA eSTAR de novos
- Letter-to-File for 510(k) clearances
- UK regulatory strategy
- EU MDD/IVDD transition strategy
- EU MDR/IVDR regulatory strategy
- EU MDR/IVDR technical documentation
This is just a sample of what I'm capable of performing - if you don't see your situation described, reach out to inquire.