The Challenge: Regulatory Change Meets a Quality Leadership Gap
With multiple product lines on the market and long-standing European presence, AngioSystems faced increasing regulatory complexity as the European Union Medical Device Regulation (MDR) replaced the legacy Medical Device Directive (MDD), requiring manufacturers to prepare for transition while continuing operations under MDD during extended timelines and notified body constraints. Maintaining uninterrupted market access while navigating this regulatory shift became a critical business priority.
At the same time, the company experienced the departure of a long-tenured internal Quality Manager, resulting in a sudden loss of institutional knowledge and day-to-day quality leadership. Compounding the situation, AngioSystems operates in a geographically limited labor market, making it difficult to recruit experienced quality leadership quickly without disrupting operations.
Supporting MDR transition activities, maintaining audit readiness, and managing ongoing quality system execution required focused expertise, yet internal leadership needed to remain dedicated to manufacturing and operational priorities.
To address these needs efficiently and without diverting internal resources, AngioSystems chose to engage experienced external quality leadership, leading them to partner with Rook Quality Systems.
Why Fractional Quality Support
Rather than pursuing a full-time hire with an uncertain timeline and high overhead, Angiosystems engaged Rook Quality Systems for targeted support. What began as a discrete MDR readiness engagement quickly evolved into an ongoing fractional quality leadership partnership.
The fractional model offered Angiosystems immediate access to senior-level quality expertise, flexibility to scale support as needs evolved, and confidence that regulatory responsibilities would be handled by specialists deeply familiar with MDR, ISO 13485, and notified body expectations.
Rook’s Approach
RQS began the engagement with a comprehensive MDD-to-MDR gap analysis, reviewing AngioSystems’ existing Quality Management System against updated MDR requirements. This assessment clearly identified where legacy processes no longer met regulatory expectations and established a prioritized, actionable remediation roadmap.
Following the gap analysis, RQS assumed responsibility for updating and aligning the QMS, handling the majority of execution with minimal hand-holding required from AngioSystems’ internal team. This approach allowed leadership to remain focused on manufacturing and operations while maintaining confidence that regulatory execution was progressing correctly.
As the engagement evolved, RQS transitioned into a fractional QMS ownership role, providing ongoing, hands-on support across:
- CAPAs, nonconformances, and complaint handling
- ISO 13485 surveillance audit preparation and execution
- Technical file support for MDR readiness
- Ongoing QMS updates driven by regulatory and operational changes
- Cross-functional coordination during a complex notified body transition
- Sterilization validation expertise
Throughout the engagement, RQS consultants acted as an extension of the AngioSystems team, providing not only individual expertise but access to a broader bench of regulatory and quality specialists as challenges arose. Transparency around scope, effort, and monthly hour utilization ensured alignment with operational and budget expectations.
The Results
With RQS serving as its fractional quality leadership partner, AngioSystems successfully:
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Prepared and aligned its QMS for MDR compliance, while continuing to operate under MDD pending timelines, regulatory extensions, and notified body availability.
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Achieved a zero-finding ISO 13485 surveillance audit
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Maintained regulatory continuity through a prolonged and complex notified body transition
- Established sustainable, ongoing QMS operations without hiring a full-time internal quality leader
By offloading day-to-day quality management and regulatory execution, AngioSystems preserved internal bandwidth and reduced organizational risk, while maintaining confidence that its quality system remained compliant, audit-ready, and actively managed.
Ongoing Partnership
Today, Rook Quality Systems continues to serve as AngioSystems’ fractional quality leadership partner, supporting ongoing regulatory execution, audit readiness, and quality system continuity.
The partnership demonstrates how established medical device manufacturers can navigate regulatory change, maintain operational focus, and achieve enterprise-level quality rigor by leveraging experienced fractional quality leadership, without the cost or constraints of a traditional full-time internal model.
