Case Study: Clinical, Risk and Technical Document Remediation for Sterile Accessories and Adapters

Project Summary:

A leading global medical device manufacturer present in over 135 countries approached Celegence to support 2 projects in compliance with European Union Medical Device Regulation (EU MDR).

  • 1
    Creation of Clinical and Post market documentation.
  • 2
    Creation and updation of risk documents, FMEAs and traceability matrix.

Customer required support in creating and updating the PMS and technical documentation including risk files to ensure that all necessary information was captured and accurately presented. The input documents curated from Agile and other databases by Celegence expert group.

Project Initiation & Key Objectives:

For Clinical writing, the customer preferred to use Celegence templates, processes and CAPTIS technology, for preparation of Clinical documents. Celegence managed to gather inputs from various databases for sales, complaints, CAPA and other required data for creation of the documents.

For the technical remediation project, the customer chose to leverage Celegence’ s team of global regulatory experts to ensure compliance of their risk documents, testing plans and reports with EU MDR and latest version of the general and product specific standards. This project included devices with various risk classifications. The objective of the project was to execute the remediation plan and update required documents as per Customer templates and processes. Additionally, Celegence managed document change control process for approval in customer PLM system.

Celegence Solution & Approach:

Celegence formed two (2) individual groups to create/ remediate clinical and technical documentation. The team comprised expert regulatory analysts, Regulatory SMEs, PMS Specialists and Consultants supporting specific requirements.

Celegence performed/supported on the following activities:

  • Celegence worked in collaboration with the customer conducting a workshop to understand mutual requirements.
  • Comprehensive review of existing documentation, identifying potential hazards, and analysing any residual risk. This also included documenting all aspects of the device such as design documents, test reports and other relevant verification and validation documents.
  • Celegence routed the updated documents in PLM system following the customer’s established document routing process.

Outcome

Celegence delivered high quality documents which includes an end-to-end process involving the right stakeholders to achieve:

  • 1
    Celegence was successful in becoming a preferred vendor for future projects.
  • 2
    The quality of deliverables was highly appreciated and acknowledged to be better than other established service providers.
  • 3
    Celegence met both quality and timelines which was the measuring factor for the choice of vendors.
  • 4
    The CAPTIS platform was well appreciated for its capability in Literature screening and analysis. The capabilities of CAPTIS in streamlining and simplifying literature review process significantly contributed to meeting quality expectations.

Project Success

The key to the continued success of this partnership is the involvement of specialized resources working in tandem with the customer’s regulatory team, and together, the two teams delivered multiple documents in expedited timelines involving Clinical Evaluation Plans & reports, Post Market Surveillance plans & reports, PMCF plans, Standard Assessment, DFMEA, UFMEA & HA, User Needs & Usability Technical Analysis, Clinical Effect Analysis, and Design Traceability documents.

Get in touch today to discuss your regulatory needs by reaching out to info@celegence.com or contact us online.