Establish what evidence would demonstrate that medical device development projects is under control.
Leading Medical Device Development Projects from Concept to Approval
Develop the judgement and the documentation needed to run medical device development projects properly.
📍 Tunis🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
Scope on medical device development projects expands through small agreements made in isolation. Stakeholders withdraw support for development projects quietly before they withdraw it formally. The programme uses small-group work so that each participant's treatment of the project and portfolio delivery capability is examined, not just described. Progress on medical device development projects is usually lost in the gap between approval and execution. This programme builds this area of project and portfolio delivery from first principles, without padding and without omitting what matters. Mature organisations treat development projects as a standing capability rather than a project that finishes. It suits anyone whose decisions touch medical device development projects, in large organisations and small ones alike. Participants gain a clear basis for measuring what development projects has actually achieved. The final session converts the week's work on the project and portfolio delivery capability into commitments with owners and dates.
Expected Learning Outcomes
Build a schedule for development projects with a genuine critical path and realistic durations.
Choose the delivery approach for medical device development projects — predictive, adaptive or hybrid — deliberately.
Integrate development projects into existing management routines rather than running it separately.
Reduce avoidable variation in how medical device development projects is carried out across teams.
Close development projects properly and capture lessons while they are still accurate.
Assess whether medical device development projects should continue at each decision gate.
Who Should Attend
Staff seconded into improvement work on medical device development projects.
Risk managers supporting development projects.
Team members preparing to take on project responsibility for medical device development projects.
Technical leads delivering work packages within development projects.
Officers preparing reports on medical device development projects for boards or oversight committees.
Project management office staff assuring development projects.
Course Modules
Medical device development projects: progress measurement and early warning
2 sessions · 8 pointsSession 1Who answers for medical device development projects, and to whom
- Record what was learned when medical device development projects did not go as planned.
- Define how the benefit from development projects will be measured after closure.
- Agree the escalation threshold for medical device development projects in advance.
- Prepare the recovery plan for development projects before it is needed.
Session 2Closing development projects and capturing what was learned
- Distinguish symptoms from causes when medical device development projects underperforms.
- Build the competence framework that supports development projects.
- Rehearse the briefing on medical device development projects that would follow an incident.
- Identify the critical path through development projects and the float elsewhere.
Development projects: governance, gates and decision rights
2 sessions · 8 pointsSession 1Decision gates on development projects that can actually stop it
- Register the risks to medical device development projects with owner, probability and impact.
- Test the procedure for development projects against a realistic scenario.
- Build the internal briefing that explains medical device development projects to those affected.
- Manage supplier performance on development projects against contract, not goodwill.
Session 2Measuring progress on development projects honestly
- Archive the decision record for medical device development projects so successors understand it.
- Establish what evidence demonstrates development projects is under control.
- Agree the smallest change to medical device development projects that would be visibly useful.
- Anticipate the objections development projects will raise and prepare the answers.
Development projects: handover, benefits and lessons
2 sessions · 8 pointsSession 1Managing suppliers delivering part of development projects
- Agree the indicators that will show whether medical device development projects is improving.
- Remove steps in development projects that add effort without adding assurance.
- Write down the assumptions underpinning the approach to medical device development projects.
- Measure progress on development projects by value earned, not tasks ticked.
Session 2The paperwork for medical device development projects that is actually needed
- Define acceptance criteria for each deliverable of medical device development projects.
- Define the decision gates for development projects and what evidence each requires.
- Map stakeholders of medical device development projects by influence and current level of support.
- Draft the minimum viable delivery plan for development projects.
Development projects: estimating cost and effort
2 sessions · 8 pointsSession 1Moving development projects from approval to execution
- Write the scope statement for medical device development projects including explicit exclusions.
- Identify where judgement in development projects is legitimate and where it is not.
- Verify six months later that changes to medical device development projects have held.
- Set out the decisions in development projects that require sign-off and by whom.
Session 2The risks to development projects nobody wants to raise
- Plan handover of medical device development projects to the team that will operate it.
- Compare resource demand from development projects against other commitments.
- Estimate medical device development projects using two independent methods and reconcile the difference.
- Review at each gate whether development projects should continue at all.
Choose the package that suits you
Silver Package
At least 3 people
USD1,250
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Gold Package
At least 3 people
USD1,850
- 5-night stay in a 5-star hotel
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Complete your registration
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