Fernandez Consulting
Global SaMD Program Direction
Rigorous strategic discipline combined with hands-on delivery, directing Class II/III Software as a Medical Device programs from strategy and governance through multi-market launch and post-market operations.
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
United States
FDA
European Union
EU MDR
United Kingdom
MHRA
Canada
Health Canada
Australia
TGA
Switzerland
Swissmedic
Extended capability: Japan · China · Brazil · Selected Asia-Pacific
The mandate
Strategy, scoping, governance, execution
One continuous arc under a single accountable direction. Most engagements begin at the first stage; recovery mandates begin wherever the program actually stands.
- 01
Strategic Scoping and Analysis
Establish the real position before committing to a plan.
Device qualification and classification, regulatory pathway selection across target markets, and an evidence gap assessment measured against the date the business has committed to. Delivered as a decision document, not a discussion.
- Qualification and classification rationale per market
- Pathway strategy across core and extended markets
- Evidence and documentation gap baseline
- Quantified exposure to the committed timeline
- 02
Program Governance and Direction
Convert strategy into a structure that can be executed.
Terms of reference, workstream architecture, named ownership and decision rights. Design control governance and phase gate criteria defined so that engineering velocity and regulatory obligation advance together rather than in tension.
- Program terms of reference and re-baselined plan
- Workstream architecture with accountable owners
- Design control governance and gate criteria
- Steering cadence and executive escalation path
- 03
Execution and Delivery
The phase where advisory engagements end and ours continues.
We hold the plan and drive it. Decisions are taken to closure, blockers removed personally, cross-functional and cross-border dependencies managed, and the evidence base completed to the standard the gate requires.
- Requirements traceability through verification and validation
- Technical documentation and design history file completion
- Risk management and cybersecurity documentation
- Gates prepared, reviewed and passed
- 04
Multi-Market Success
Launch is a milestone, not the finish line.
Market entry sequenced so that a single body of evidence serves as many submissions as the requirements allow, followed by the surveillance and change control obligations that begin on the day of release.
- Sequenced multi-market submission strategy
- Notified body and agency interaction management
- Post-market surveillance and vigilance readiness
- Change control and lifecycle governance
The distinction
Where advisory engagements conclude, the mandate continues
The scoping stage would be familiar to anyone who has bought from a top-tier firm. What follows it is not.
Conventional advisory
- A findings pack and a set of recommendations
- An implementation roadmap for another team to run
- Risks identified, logged and handed over
- Success measured by acceptance of the report
Fernandez Consulting
- Decisions taken to closure and recorded
- The plan executed under our direction
- Blockers removed personally and escalated early
- Success measured by the gate passed and the market entered
Capability
Where the program and the regulation meet
Class II/III software programs fail at the seams between functions. Direction is held across all of them rather than within any single one.
SaMD Program Direction
Direction of Class II/III software programs where delivery, regulatory compliance and patient safety cannot be separated from one another.
Multi-Market Regulatory Strategy
FDA, EU MDR, MHRA, Health Canada, TGA and Swissmedic pathways sequenced as one coordinated program rather than as separate, duplicated submissions.
Lifecycle Governance
IEC 62304 lifecycle processes and ISO 13485 quality systems applied so that they describe how the organization genuinely builds software.
Design Control and Traceability
A traceable path from requirements and design controls through verification, validation and release that withstands notified body and agency review.
Interoperability
HL7 FHIR and connected clinical systems, where integration risk across hospital environments is program risk and must be governed as such.
Medical Device Cybersecurity
Security requirements, threat modeling and documentation carried inside the delivery plan rather than raised as a premarket surprise.
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
When we are engaged
Programs at the point where direction decides the outcome
- A committed submission or launch date is materially at risk
- Program leadership is vacant and the program cannot pause
- Evidence is incomplete against a fixed regulatory timeline
- Dependencies span functions, sites and jurisdictions
- Multi-market entry requires coordinated regulatory sequencing
- Senior direction is required continuously but short of a permanent hire
Engagement models
Interim, fractional and embedded direction
The arc is constant. What varies is what is held, at what commitment, and over what term.
Interim Program Direction
Embedded leadership of a Class II/III program during a vacancy, transition or capability gap. We hold the plan, chair the governance and carry the milestone dates until a permanent appointment is made and the mandate handed over.
Fractional Program Direction
Continuous senior direction for organizations requiring genuine regulatory-delivery judgment across release cycles without a full-time appointment.
Program Recovery
Time-boxed intervention where priorities, evidence or cross-functional friction have stalled delivery. The first phase establishes the true position; the remainder restores a credible, owned path to release.
Submission and Gate Readiness
Direction of a defined workstream to a specific gate, covering requirements traceability, verification and validation readiness, and technical documentation completeness — assessed against the standard the gate applies, then driven closed.
Specialist Augmentation
Where a workstream exceeds the capacity an organization can release internally, we mobilize qualified specialists under our direction and inside your quality system. A specialist can typically be placed within days.
EU MDR PRRC Support
Article 15(6) permits micro and small enterprises to hold the Person Responsible for Regulatory Compliance externally, provided that person is permanently and continuously at the manufacturer's disposal. Above that threshold we support the appointed PRRC rather than hold the role.
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.