Fractional RA/QA
Maintaining continuous regulatory and quality oversight under the MDR and IVDR requires specialised expertise that many organisations struggle to retain in-house. Smaller manufacturers, startups, and rapidly scaling enterprises often operate with limited regulatory resources, relying on individuals who balance multiple responsibilities across quality, design, and operations. As regulatory complexity increases, this model becomes unsustainable. The absence of experienced leadership in Regulatory Affairs (RA) and Quality Assurance (QA) can lead to delays in certification, audit findings, and systemic compliance risks.
Our Fractional RA/QA services address this challenge by providing clients with access to senior regulatory and quality professionals on a part-time, project-based, or interim basis. This model enables organisations to maintain the same standard of oversight and strategic guidance as a full-time compliance department, without incurring the associated cost or administrative burden.
We begin by conducting a focused assessment of your current compliance infrastructure, identifying areas requiring leadership, documentation enhancement, or operational reinforcement. Based on this assessment, we allocate specialised RA/QA experts with experience relevant to your device class, regulatory pathways, and market geography. Our consultants integrate seamlessly with your internal teams, assuming designated responsibilities while maintaining a strategic focus on long-term compliance sustainability.
Typical engagements include:
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Acting as interim Quality or Regulatory Manager during transitions or recruitment periods.
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Providing regulatory strategy and submission planning for MDR, IVDR, or other jurisdictional approvals.
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Overseeing QMS implementation, internal audit programs, and CAPA management.
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Coordinating communication with Notified Bodies, Competent Authorities, and suppliers and supporting post-market surveillance, vigilance, and change control processes.
Each engagement is customised to align with organisational priorities and maturity. For early-stage companies preparing for first certification, fractional RA/QA resources provide the structure and documentation discipline necessary to establish compliant operations from the outset. For established manufacturers, our consultants strengthen existing teams by addressing workload peaks, specific remediation projects, or audit preparation needs.
The value of this model lies in flexibility and depth. Clients benefit from access to senior-level expertise precisely when required, without the long-term financial commitment of full-time employment. Our consultants bring regulatory insight informed by direct experience with Notified Bodies, Competent Authorities, and international markets. This perspective ensures that strategic decisions are informed by current regulatory interpretations and emerging expectations.
Engagements are supported by standardised documentation tools, reporting templates, and communication protocols to ensure transparency and continuity. Each assignment includes defined objectives, measurable outcomes, and knowledge transfer mechanisms that strengthen internal capability even after engagement completion.
By leveraging fractional RA/QA support, organisations can maintain continuous compliance oversight, respond rapidly to regulatory developments, and allocate resources more efficiently. This model is particularly effective for companies expanding their product portfolios, entering new markets, or managing certification renewals under constrained timelines.
Effective compliance management requires both strategic insight and operational execution. Our Fractional RA/QA services provide the leadership continuity, regulatory assurance, and flexibility necessary to sustain compliance while optimising resources.
For further information on how our Fractional RA/QA services can support your organisation’s regulatory and quality objectives, please contact our consulting team.
