THE PROJECT

A leading global company offering medical technology, services, and solutions engaged RQM+ to help four business units prepare for the EU Medical Device Regulation (MDR). Specifically, RQM+ is focused on assessing and remediating gaps in MDD technical files and building compliant MDR technical documentation files for submission.

THE CHALLENGE

The company had a well-defined EU MDR plan and a proactive strategy to outsource EU MDR compliance activities in order to stay on track. To allow internal resources to remain focused on New Product Introduction (NPI), the client appointed RQM+ to manage several EU MDR workstreams and to prepare regulatory submission documents for EU MDR.

THE BRIEF

RQM+ was appointed to deliver EU MDR solutions on a managed outsourced basis. The client had already carried out their own gap assessments so RQM+ was able to identify and deliver an action plan from day one. From its portfolio of EU MDR compliance solutions, RQM+ assisted with risk management; evaluation against current standards; and materials of concern. RQM+ deployed an expert team, tailored to the client’s requirements, with experience across diverse areas, including quality engineering, risk management, standards, microbiology, clinical evaluation, and quality system compliance.

HOW RQM+ DELIVERED

RQM+ has been partnering with the client on EU MDR preparedness by remaining flexible, focused, and applying specialized skills in order to keep them on track. The client’s goal is to ensure that the required products are EU MDR ready, well ahead of the recertification dates. RQM+ has also been able to react to the needs of the organization for the additional services the client required as the project progressed. RQM+ started off supporting the client in Design History File (DHF) remediation and quickly expanded into several areas where there were internal resource constraints and skills gaps.

Gap Assessments

  • The client wanted to bring in an experienced third party to review all the regulatory technical files and identify the gaps which need to be corrected before the MDR submission.
  • A breadth of documents was included as part of this process which requires a tremendous number of resources and effort: DHFs, clinical evaluation, post-market surveillance, manufacturing, sourcing, and quality management system (QMS).

Remediation

RQM+ led the remediation effort by:

  • holding an on-site workshop to review each gap and describe the expected remediation path and deliverables;
  • working in partnership with client subject matter experts (SMEs) and process owners to address issues and approve deliverables;
  • transferring knowledge to client SMEs, as needed;
  • and reviewing documentation of objective evidence and updated risk, clinical and post-market documentation;
  • impact assessments of changes to standards to ensure compliance to state of the art (SOTA) requirements.

Submission

The experienced RQM+ team proceeded to prepare all necessary technical and supporting documentation in order to provide a smooth pathway to regulatory submission by:

  • migrating legacy data from MDD technical files to new MDR technical documentation templates;
  • gathering pertinent data from across the EU MDR workstreams to update technical documentation;
  • and drafting position papers to provide missing rationales and summarize evidence collected in support of new requirements.

Reporting

To create successful working partnerships, RQM+ implemented consistent and clear communications procedures:

  • a remediation log and tracking tool documenting assignments, activities, and project status;
  • executive summaries of key issues identified during gap assessments of each product
  • weekly summary status reports of completed and upcoming activity
  • core team and governance board meetings during the remediation stage to discuss risks, issues, and escalations.

THE RESULT

By partnering with RQM+, the client is able to proactively implement its strategic goal of product remediation well in advance of recertification deadlines. Completion of the project is on track and each gap has been closed. RQM+ identified additional gaps in the company QMS which were then communicated to the client, ensuring thorough audit readiness. The client’s EU MDR assessment tools are now consistent with tools used by other units of the business. Due to the success of the initial project, further business units from the same company are now looking to RQM+ for support on their EU MDR compliance activities. Working across the corporation, RQM+ has been sharing best practices amongst all the different business groups and units within the organization.

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