October 14, 2026 • Live Virtual Webinar
LIVE EXECUTIVE WEBINAR
Notified Body Ready?
Find the evidence gaps a Notified Body reviewer may question—before your next review.
Your technical documentation can be complete and still generate difficult Notified Body questions. This session shows MedTech regulatory, clinical, and quality leaders how to stress-test their evidence package, Claims → CER → PMCF → PMS → Risk → SSCP, before submission, renewal, or the next response cycle.
October 14, 2026 | 9:00–10:00 AM Pacific / 12:00–1:00 PM Eastern | Live Virtual Webinar
Reserve My Seat
Free registration • Live Q&A • Readiness checklist included.
Informed by 18+ years in MedTech, work across 75+ Class I–III medical devices, and global (EU & US) submissions across cardiovascular portfolios.
MDR EXPERIENCE, VALIDATED BY A MEDTRONIC PROGRAM LEADER
“I’m pleased to recommend Shola, an outstanding Senior Clinical Research Program Manager who played a pivotal role in Medtronic Cardiac Surgery’s journey to achieving MDR CE Mark designation across our legacy product portfolio.”
Craig Pilarski
Program Director, CardioVascular Surgery, Medtronic
Program Director, CardioVascular Surgery, Medtronic
A complete technical file can still be unready for Notified Body review.
The required documents may all be present. The CER may be current. PMCF may be underway. PMS and risk documentation may each look defensible on their own. Yet the package can still invite difficult questions when those documents do not support one consistent evidence position.
Review may expose gaps between:
- Claims and the clinical evidence supporting them
- CER conclusions and PMCF priorities
- Post-market findings and updated clinical or risk conclusions
- Benefit-risk conclusions and the breadth of the claims
- Different documents describing the same device in different ways
PRACTICAL TAKEAWAYS
What you will learn
Distinguish
A technically complete file from a review-ready evidence package.
Identify
The evidence interfaces most likely to create Notified Body questions.
Stress-test
Alignment across Claims → CER → PMCF → PMS → Risk Management → SSCP.
Recognize
When repeated deficiencies may signal a system-level evidence or governance problem.
Determine
What should be addressed before submission, renewal, or the next response cycle.
SELF-ASSESSMENT
Is this session right for you?
This session is for teams approaching submission, renewal, or a deficiency response who are unsure whether their claims, clinical evidence, post-market findings, and risk conclusions tell one consistent story.
REVIEW THROUGH THE INTERFACES
The Evidence Alignment Stress Test
A practical way to examine whether the core components of your evidence package reinforce one another, or create tension a reviewer may expose.
Evidence interface
Question to ask
Claims ↔ CER
Can each material claim be traced to sufficient and relevant clinical evidence?
CER ↔ PMCF
Does PMCF address the gaps and uncertainties identified in the clinical evaluation?
PMS ↔ CER
Are post-market signals reflected in the clinical conclusions?
PMS ↔ Risk
Have complaints, trends, and vigilance findings appropriately informed the risk position?
Risk ↔ Claims
Does the benefit-risk position support the breadth of the claims being made?
SSCP ↔ CER
Does the SSCP consistently reflect the clinical evaluation conclusions, residual risks, and claims?
BUILT FOR THE PEOPLE CARRYING THE EVIDENCE RISK
Who should attend
This session is designed for MedTech leaders responsible for evidence defensibility, market continuity, and successful EU MDR review.
VPs and Heads of Regulatory Affairs
Clinical Affairs leaders
Quality leaders
Regulatory and Clinical Directors
EU MDR program leaders
General Managers and Business Unit leaders with responsibility for portfolio or market continuity
Especially relevant for Class IIb and Class III portfolios
where legacy documentation, evidence complexity, and cross-functional dependencies increase review risk.
where legacy documentation, evidence complexity, and cross-functional dependencies increase review risk.
AN OPERATOR’S VIEW
This is not another webinar explaining the MDR.
It’s an operator’s view of what happens when documentation meets review and how to look across the evidence package for the inconsistencies, unresolved questions, and weak interfaces that can create avoidable review cycles.
“My objective is not to teach you the MDR. It is to help you see the questions your evidence package may invite before your reviewer asks them.”
Dr. Shola Sulaimon
YOUR SPEAKER
Dr. Shola Sulaimon
DVM, MSc, PhD
Founder & CEO | SHOTUNE Medical Consulting Group
Dr. Shola Sulaimon is a MedTech strategist and former Medtronic clinical research leader with 18+ years in the medical device industry, spanning clinical, regulatory, quality, and portfolio decision-making.
Her experience includes work across 75+ Class I–III medical devices, including cardiovascular products, and 75+ European medical device submissions under MDD/MDR across cardiovascular portfolios. Her work has included clinical evidence strategy, MDR remediation, Notified Body deficiency response, submission-integrity review, portfolio rationalization, and cross-functional decision-making where clinical, regulatory, quality, and commercial risks converge.
Through SHOTUNE Medical Consulting Group, she advises MedTech leaders on identifying portfolio and evidence risks before they narrow strategic options, delay market access, or threaten market continuity.
FROM PEOPLE WHO WORKED WITH HER
What leaders and colleagues say about working with Dr. Shola.
These recommendations come from leaders and colleagues who worked with Dr. Shola at Medtronic and speak to the judgment, leadership, and cross-functional work behind her experience.
“Dr. Shola is good at her craft under pressure — the kind of technical judgment that shows up when the deadline’s tight and the expectations are high. … She always showed up with a can-do approach.”
Eric Klavetter
CardioVascular Surgery, Medtronic — managed Shola directly
CardioVascular Surgery, Medtronic — managed Shola directly
“Shola and I worked together at Medtronic. Shola Sulaimon demonstrated strong leadership in driving work across regulatory, clinical, quality, and evidence strategy, ensuring alignment across functions and consistent focus on end-to-end submission readiness.”
Maia Tatum, PharmD, PMP, MS, RPh
Healthcare Leader, Enterprise Transformation | Clinical Evidence Strategy | Patient Access & Health Equity Advocate
Healthcare Leader, Enterprise Transformation | Clinical Evidence Strategy | Patient Access & Health Equity Advocate
“I had the privilege of working alongside Dr. Shola Sulaimon at Medtronic, and she is one of the most complete clinical-regulatory leaders I’ve encountered in MedTech.”
Kemi Williams, PhD, MBA
Clinical Operations Executive | Population Science & Business Strategy
Clinical Operations Executive | Population Science & Business Strategy
Leave with a tool you can use immediately.
Registered attendees receive the SHOTUNE Notified Body Readiness Checklist, a practical pre-review diagnostic designed to help teams examine the areas most likely to deserve attention before technical documentation reaches the Notified Body.
Use it with your regulatory, clinical, and quality teams to identify where documentation is aligned, where tension exists, and where a contradiction may require a management decision.
SESSION DETAILS
Webinar agenda
01
Where apparently complete files become vulnerable
02
The Evidence Alignment Stress Test
03
What to address before review
04
Q&A
Final timing within the session may be adjusted to preserve adequate Q&A time.
FOR ORGANIZATIONS THAT NEED DEEPER SUPPORT
Need to go beyond the webinar?
SHOTUNE works directly with MedTech organizations preparing for Notified Body review through a focused 10-Day EU MDR Evidence & Notified Body Readiness Review.
The review stress-tests the evidence package before formal scrutiny, identifies the most consequential gaps and contradictions, and gives leadership a prioritized view of where action is needed.
The webinar will explain how the readiness approach works. Organizations that need deeper support can discuss applying it to their own documentation.
Don’t wait for the Notified Body to identify the first contradiction.
Join us October 14 to examine the evidence gaps that may invite questions and leave with a checklist to use with your team.
October 14, 2026 | 9:00–10:00 AM Pacific / 12:00–1:00 PM Eastern | Live Virtual Webinar