EXECUTIVE SESSIONS
The organisation decides what you can see.
You remain answerable either way.
The organisation decides what you can see.
You remain answerable
either way.
The organisation decides what you can see.
You remain answerable either way.
DIFFERENT SITUATIONS. THE SAME KIND OF RESPONSIBILITY.
These sessions are for MedTech founders and executives who shape or lead the organisation as a whole.
Each session starts from a different situation. What they share is a focus on questions that cannot simply be delegated to a function.
These sessions are for MedTech founders and executives who shape or lead the organisation as a whole.
Each session starts from a different situation. What they share is a focus on questions that cannot simply be delegated to a function.
Regulatory execution architecture
for scaling MedTech companies.
WHO IT IS FOR
WHO IT IS FOR
WHO IT IS FOR
Founders building the organisation around their product.
CEOs, Managing Directors and other leaders with responsibility across functions and decisions.
The common ground is not title or company size. It is responsibility beyond a single function.
Founders building the organisation around their product.
CEOs, Managing Directors and other leaders with responsibility across functions and decisions.
The common ground is not title or company size. It is responsibility beyond a single function.
Founders building the organisation around their product.
CEOs, Managing Directors and other leaders with responsibility across functions and decisions.
The common ground is not title or company size. It is responsibility beyond a single function.
WHAT YOU GET
WHAT YOU GET
WHAT YOU GET
A clearer view of what your role requires from the organisation around you.
Questions that help expose what may remain hidden between functions, processes and reporting.
A framework you can take back into your organisation and continue using.
A clearer view of what your role requires from the organisation around you.
Questions that help expose what may remain hidden between functions, processes and reporting.
A framework you can take back into your organisation and continue using.
A clearer view of what your role requires from the organisation around you.
Questions that help expose what may remain hidden between functions, processes and reporting.
A framework you can take back into your organisation and continue using.
HOW IT WORKS
HOW IT WORKS
HOW IT WORKS
Four hours.
Maximum six participants.
Live online, camera on, no recording.
Confidential.
Facilitated conversation and structured reflection rather than presentation or compliance training.
Four hours.
Maximum six participants.
Live online, camera on, no recording.
Confidential.
Facilitated conversation and structured reflection rather than presentation or compliance training.
Four hours.
Maximum six participants.
Live online, camera on, no recording.
Confidential.
Facilitated conversation and structured reflection rather than presentation or compliance training.
Founder Series
For founders building the organisation around the product.
FOUNDER SERIES · FS-01
FOUNDER SERIES · FS-01
FOUNDER SERIES · FS-01
Build ISO 13485 around the company. Not the company around the standard.
Build ISO 13485 around the company. Not the company around the standard.
Build ISO 13485 around the company. Not the company around the standard.
For early-stage MedTech founders deciding when to introduce ISO 13485, what to build now and what can wait.
For early-stage MedTech founders deciding when to introduce ISO 13485, what to build now and what can wait.
For early-stage MedTech founders deciding when to introduce ISO 13485, what to build now and what can wait.
Four hours on the decisions that shape the company around the product: when to start, how much structure is enough, and which early choices become difficult to reverse.
Four hours on the decisions that shape the company around the product: when to start, how much structure is enough, and which early choices become difficult to reverse.
Four hours on the decisions that shape the company around the product: when to start, how much structure is enough, and which early choices become difficult to reverse.
Four hours · Max six participants · Live online
Four hours · Max six participants · Live online
Four hours · Max six participants · Live online
Explore FS-01
Executive Series
For executives accountable for an organisation that has already grown.
EXECUTIVE SERIES · ES-01
EXECUTIVE SERIES · ES-01
EXECUTIVE SERIES · ES-01
Accountability stays with the CEO. Visibility does not follow automatically.
Accountability stays with the CEO. Visibility does not follow automatically.
Accountability stays with the CEO. Visibility does not follow automatically.
For CEOs and Managing Directors accountable for an organisation they can no longer see in full.
For CEOs and Managing Directors accountable for an organisation they can no longer see in full.
For CEOs and Managing Directors accountable for an organisation they can no longer see in full.
Four hours on the gap between what you answer for and what the organisation still shows you, using ISO 13485 Chapter 5 as a leadership framework rather than a compliance reference.
Four hours on the gap between what you answer for and what the organisation still shows you, using ISO 13485 Chapter 5 as a leadership framework rather than a compliance reference.
Four hours on the gap between what you answer for and what the organisation still shows you, using ISO 13485 Chapter 5 as a leadership framework rather than a compliance reference.
Four hours · Max six participants · Live online
Four hours · Max six participants · Live online
Four hours · Max six participants · Live online
Explore ES-01
EXECUTIVE SERIES · ES-02
EXECUTIVE SERIES · ES-02
EXECUTIVE SERIES · ES-02
The Management Review happens once a year. Management does not.
The Management Review happens once a year. Management does not.
The Management Review happens once a year. Management does not.
For CEOs and Managing Directors who hold a Management Review that is compliant, documented and does not change anything.
For CEOs and Managing Directors who hold a Management Review that is compliant, documented and does not change anything.
For CEOs and Managing Directors who hold a Management Review that is compliant, documented and does not change anything.
Four hours on what reaches the review, who answers for it, and what would have to be different for it to govern rather than report.
Four hours on what reaches the review, who answers for it, and what would have to be different for it to govern rather than report.
Four hours on what reaches the review, who answers for it, and what would have to be different for it to govern rather than report.
Four hours · Max six participants · Live online
Four hours · Max six participants · Live online
Four hours · Max six participants · Live online
Explore ES-02