CASE STUDY
Updating 6 Clinical Evaluations in 6 Months for a Notified Body Audit to Maintain a CE-Mark
Consultant: Jaani Gandhi
EU MDR 2017/745 Annex XIV
MEDDEV 2.7/1 Rev 4
Our Results
Evaluations
Timeline
& No Rework
THE PRODUCTS
Cardiac Surgical Devices
A global leader in cardiac surgery, developing Class IIb and III devices for heart valve replacement, minimally invasive procedures, and pulmonary bypass.
THE CHALLENGE
6 Months to a Notified Body Review
The client entered the engagement with six product families requiring complete Clinical Evaluation Plans and Reports under MDR — with FDA and Notified Body audits looming.
A previous consultant had been engaged and delivered nothing, leaving the team with outdated documentation, half the original timeline, and no bandwidth to close the gap internally.
Audit deficiencies trigger costly rework cycles, and repeated deficiencies risk device removal from market — threatening both patient access and Edwards' standing as a supplier.
THE APPROACH
Harmonizing evidence to tell the clinical story
To address this, we focused on rapid product mastery and a gap analysis across existing documentation, with an emphasis on eliminating redundant effort across the portfolio from day one.
Key elements of the approach included:
Modular SOTA architecture: Rather than producing six independent background documents, we engineered a single modular reference leveraged across all six CERs - reducing both current production time and future update burden.
Parallel clinical evaluation execution: All six workstreams ran in a compressed, sequenced timeline — consistent methodology across the portfolio, tailored evidence synthesis per device. While the first CER went for cross-functional review, the next was being drafted.
Audit-readiness as the primary quality lens: Every deliverable was built against FDA and Notified Body scrutiny standards - not just internal requirements - ensuring nothing required rework during the audit cycle.
This allowed the team to close the entire documentation gap in 6 months, with zero rework required.
THE OUTCOME
No Deficiencies, No Rework, and Products Cleared to Sell
The client emerged with six fully MDR-compliant Clinical Evaluation Plans and Reports, cleared by both the FDA and Notified Body with zero deficiencies - preserving a minimum of $60,000–$120,000 in avoided rework costs.
The product families now carry clean, portable regulatory packages that enabled divestiture into a newly spun-off company, and the organization is positioned for ongoing MDR lifecycle management from a foundation of structured, audit-tested documentation.
Facing a similar challenge?
Whether you’re pre-market, sustaining, or facing a mountain of deficiencies, having the right clinical strategy and structure in place makes all the difference. Let’s talk about where you are, what’s getting in the way, and how to create momentum.