Process Flow – Retainership Model
A Retainership Model for medical devices provides an ongoing, long-term partnership where a dedicated regulatory and quality expert serves as an extension of your internal team. This model ensures continuous compliance, rather than one-time project completion, which is vital for maintaining market access in a highly regulated industry.
Retainership Model Process Flow
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1. Onboarding & Requirement Assessment
The partnership begins by defining the relationship's scope, including the specific devices, target markets, and required services (e.g., QMS maintenance or technical file updates). A thorough assessment of the company’s current status helps establish clear goals and timelines for the engagement. -
2. Gap Analysis & Compliance Roadmap
Experts perform a systematic examination of your existing documentation against current regulations like ISO 13485, IMDR 2017, EU MDR, or FDA 21 CFR Part 820. This leads to a Compliance Roadmap—a prioritized action plan to remediate any identified non-conformities -
3. QMS Maintenance & Implementation Support
Once a Quality Management System (QMS) is established, it requires constant updates to stay effective. Retainer support includes:
• Updating Standard Operating Procedures (SOPs) based on process changes.
• Managing the Document Control system to ensure only current versions are in use.
• Integrating new requirements into existing frameworks. -
4. Regulatory Compliance Management:
The retainer partner acts as a proactive advisor, identifying risks before they lead to regulatory violations. This involves managing Post-Market Surveillance (PMS) data, overseeing registration renewals, and ensuring compliance with evolving standards like REACH or RoHS. For EU markets, this may include providing a Person Responsible for Regulatory Compliance (PRRC). -
5. Training & Awareness Programs
Continuous staff training ensures that every employee understands their role in the quality system. Regular sessions cover new regulatory updates, proper documentation practices, and specific SOP requirements to maintain a "culture of quality". -
6. Internal Audits & Mock Inspections
• Internal Audits: Scheduled impartial assessments verify that the QMS operates as intended and meets regulatory requirements.
• Mock Inspections: These act as a "rehearsal" for real Regulator (FDA) or Notified Body audits, helping teams practice their response strategies and identify potential issues before an actual investigator arrives. -
7. Management Review & Reporting
Periodic reports are provided to top management to analyze QMS performance. These reviews use data to evaluate quality objectives, audit results, and resource needs, ensuring leadership remains accountable for the system's effectiveness. . -
8. . Continuous Improvement & Updates
The final stage is a continuous loop where the retainer partner uses feedback from audits and PMS to enhance processes. This "Plan-Do-Check-Act" (PDCA) cycle ensures the quality system matures over time, leading to more efficient operations and higher product reliability.