Leadership
Jose Fernandez
Principal — Global SaMD Program Direction. Class II/III software programs directed from strategic scoping through multi-market launch and post-market operations.
Fernandez Consulting is directed by its Principal. Mandates are led personally rather than delegated to an analyst bench, and the person who scopes the program is the person accountable for delivering it.
The practice exists because Class II/III software programs rarely fail for want of analysis. They fail at the seams — between engineering and regulatory, between sites and jurisdictions, between a strategy that was written and a plan that was never driven. Direction across those seams is what is offered here.
Programs directed have placed platforms into service across approximately 4,000 hospitals and clinics worldwide, bringing product, engineering, regulatory, quality, cybersecurity and operational functions onto a single traceable path from requirements and design controls through verification, validation, release and lifecycle maintenance.
We do not conclude at recommendations.We remain accountable for outcomes.
Every program is scoped with the rigor of a top-tier strategy engagement and then delivered with full ownership — through governance, stage gates, and into the markets it was designed to serve.
Core markets directed
United States
FDA
European Union
EU MDR
United Kingdom
MHRA
Canada
Health Canada
Australia
TGA
Switzerland
Swissmedic
Standards
- IEC 62304
- ISO 13485
- ISO 14971
- IEC 62366
- FDA 510(k)
- EU MDR
- UKCA
- MDSAP
- HL7 FHIR
The dual strength
Consulting discipline and delivery accountability in one seat
These are ordinarily bought separately — a firm to define the strategy, a contractor to execute it, and a gap between them where programs are lost.
Strategic depth
Programs are scoped and structured with the analytical discipline of a top-tier strategy engagement: the position established before the plan, the exposure quantified, and decisions framed for the executive who must take them.
Delivery capability
That structure is then executed. Requirements, design controls, verification and validation, technical documentation and submissions are driven to completion inside the client's quality system.
Global program leadership
Direction of programs spanning functions, sites and jurisdictions, where regulatory sequencing across markets and cross-border dependencies determine whether a committed date holds.
Global reach
Programs directed across regulated markets worldwide
Multi-market entry is planned as a single sequence, so that evidence generated once serves more than one submission wherever the requirements permit.
Core markets
United States
FDA
510(k) · De Novo
European Union
EU MDR
CE marking
United Kingdom
MHRA
UKCA
Canada
Health Canada
MDSAP
Australia
TGA
ARTG inclusion
Switzerland
Swissmedic
MedDO
Extended capability
Japan
PMDA
China
NMPA
Brazil
ANVISA
Selected Asia-Pacific
Market-specific
Extended markets are directed in coordination with local authorized representatives and in-country agents, under the same program governance as the core markets.
~4,000
hospitals and clinics running platforms delivered under programs we have directed
Class II/III
software device programs, where evidence and patient safety carry the greatest weight
10+
regulatory markets across North America, Europe, Asia-Pacific and Latin America
Engage
High-stakes programs deserve a direct conversation.
If you are accountable for a Class II or III software program under regulatory or delivery pressure, we should speak. If the mandate is not one we should hold, you will be told so directly.