Program Direction
One mandate, from scoping to market
We direct Class II/III Software as a Medical Device programs across the full arc — establishing the strategy, building the governance, executing the plan, and carrying the program into every market it was built for.
The arc
Strategic scoping, governance, execution, multi-market
Each stage has defined outputs and a defined close. The scoping stage is fixed-fee and standalone: no mandate is committed to before the position is established and the exposure quantified.
- 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.
Defined outputs
- 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.
Defined outputs
- 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.
Defined outputs
- 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.
Defined outputs
- Sequenced multi-market submission strategy
- Notified body and agency interaction management
- Post-market surveillance and vigilance readiness
- Change control and lifecycle governance
Engagement models
Interim, fractional and embedded direction
Selection follows the situation rather than a service menu. Where more than one applies, the scoping stage resolves which mandate is the correct entry point.
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.
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.
Capability
Directed across every function the program touches
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.
Governance and boundaries
How external direction remains audit-defensible
External leadership inside a regulated program creates obligations on both sides. These are established before a mandate begins, not discovered during an inspection.
The manufacturer retains responsibility
Regulatory responsibility and final decision authority remain with the legal manufacturer. We direct programs and drive decisions to closure; we do not displace accountable decision-makers.
Engaged as a qualified supplier
These services are a purchased input to your quality system under ISO 13485 §7.4 and 21 CFR 820.50. We provide the qualification evidence your procedures require.
Specialists qualified before they start
Personnel placed under an augmentation mandate are competence-assessed and trained to your applicable procedures before performing work, with records maintained per ISO 13485 §6.2.
Independence preserved
We do not audit processes we have designed or directed, consistent with ISO 13485 §8.2.4. Independent assessment of our own work is sourced separately.
Roles that must be held internally
The ISO 13485 management representative must be a member of your own management. The same applies to the PRRC above the micro and small enterprise threshold. We will say so rather than accept an appointment that will not withstand audit.
No guaranteed outcomes
No external party can guarantee clearance, certification or a notified body decision, and no fee here is contingent on one. What is committed to is defined scope, visible progress and evidence that withstands review.
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.