Medical Device Lifecycle Management

Continuous monitoring and updating of reports, including Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), and Periodic Safety Update Reports (PSURs), are essential throughout a medical device's lifecycle, spanning research and post-market oversight. Freyr, with a decade of experience in medical writing, ensures top quality and compliance in medical device lifecycle management.

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Medical Device Lifecycle Management – Overview

Medical writing is a meticulous process of creating documentation and translating complex scientific and clinical data into clear, concise, and well-structured documents that meet the stringent requirements of Health Authorities (HAs). In the ever-evolving landscape of medical advancements and Regulatory requirements, medical device lifecycle management for medical writing documents plays a key role in ensuring the safety and compliance of medical devices as well as In Vitro Diagnostics (IVDs). It is, in fact, one of the most important aspects of Regulatory submission strategy.

A Post-market Surveillance (PMS) plan is designed to generate information in the form of a PMS report regarding the use of a device to expediently identify device design and/or usage problems and accurately characterize the real-world behavior of a device along with the clinical outcomes.

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Importance of Medical Device Lifecycle Management of Reports

The creation, production, and distribution of a medical device entails intricate procedures that extend over several years, covering phases such as research, development, clinical trials, Regulatory endorsements, post-market oversight, and continuous monitoring. Throughout the product lifecycle journey, the knowledge and data accumulated must be meticulously compiled, assessed, and disseminated to ensure that products remain safe and effective.

Compliance is not a one-time event, but rather, it is a continuous process until the time your medical device is placed on the market. Understanding the fundamentals of managing a product's lifecycle from the outset can help you prevent costly delays and inefficiencies that might arise due to non-compliance or unforeseen challenges later.

What reports should be updated from time to time?

  • Clinical Evaluation Reports (CERs): CERs should be periodically reviewed and updated to incorporate new clinical data, PMS findings, and any emerging safety concerns.
  • Performance Evaluation Reports (PERs): Similar to CERs, PERs should be revisited to reflect changes in technology, manufacturing processes, and performance data. Ongoing monitoring and reassessment are essential to ensure that IVDs continue to meet their intended purpose accurately.
  • Clinical Performance Reports (CPRs): Regular updates to CPRs may be necessary to incorporate new clinical data, address emerging safety concerns, and reflect changes in clinical practices or guidelines.
  • Analytical Performance Reports (APRs): Regular updates to APRs may be required to reflect improvements in testing methodologies, changes in reference materials, or technological advancements.
  • Scientific Validity Reports (SVRs): Updating SVRs is required for incorporating new scientific findings, addressing feedback from Regulatory agencies or experts, and reflecting changes in the state of scientific knowledge.
  • Periodic Safety Update Reports (PSURs): PSURs are designed to provide an up-to-date assessment of a medical device’s safety profile. Regular updates are crucial to include new adverse event data, emerging safety signals, and any changes in the risk-benefit balance of devices.
  • PMS Reports (PMSR): Much like PSURs, PMSRs have to be updated continually to include data from PMS activities, such as adverse event reporting, complaints, and user feedback. PMS reports help identify and address potential safety issues in real-world settings.

Effective medical device product lifecycle management of CERs, PERs, and PSURs is vital for ensuring continuity of your medical devices and IVDs in the market. Following best practices and staying up to date with regulations is the right approach for ensuring compliance of your products.

With a decade of experience in the field of medical writing, Freyr has a robust delivery model that ensures optimized performance with superior quality.

Medical Device Lifecycle Management

  • Clinical Evaluation Plan/Reports
  • Performance Evaluation Plan/Reports
  • CPRs
  • APRs
  • SVRs
  • Summary of Safety and Performance (SSP) Report
  • Lifecycle Management of Medical Writing Reports
  • Gap Analysis of Previous CERs, PERs, and the Related Source Documents
  • PMS Plan
  • PMS Report
  • Post Market Clinical Follow Up (PMPF) Plan
  • Post Market Clinical Follow Up (PMCF) Report
  • PSURs
  • Assured compliance with recent applicable regulations.
  • A team of qualified experts.
  • Solutions tailored to your requirements.
  • Regulatory resource management/staff augmentation services.
  • Cross-functional inputs from medical device experts to help you comply with regulations.

For end-to-end Regulatory partnership on PMS, reach out to Freyr!