Systematic Literature Searches for Regulatory Compliance

Expert support from the literature search protocol to data extraction and analysis

Need a validated search protocol?

BioTop Medical supports you with systematic literature searches based on PRISMA, PICO and MEDDEV 2.7/1—compliant and ready for submission.

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A systematic, unbiased literature search is a mandatory component whether for clinical evaluation, performance evaluation or PMCF. At BioTop Medical, we provide full support—from defining your PICO-based question, to the search, appraisal, and data extraction of the results.

Types of Systematic Literature Searches: State-of-the-Art & Performance and Safety

Systematic literature searches can serve several objectives depending on the development phase and regulatory need:

  • State-of-the-art (SOTA) search: Evaluate current medical practice and alternative technologies early in development or in post-market.
  • Performance and safety literature search: Support clinical or performance evaluation by collecting pre-clinical and clinical data on the device itself or equivalent devices.
  • Post-marketing surveillance (PMS): Continuously monitor safety and performance during the device life cycle.
  • Post-market clinical follow-up (PMCF): Gather real-world data on long-term safety and effectiveness.

Phases of a Systematic Literature Search

Our systematic literature searches follow a structured, reproducible process:

  • Protocol: Formalizes how the search will be performed.
  • Raw searches: Use of relevant databases and tailored/planned Boolean queries.
  • Title selection: Based on predefined inclusion/exclusion criteria.
  • Appraisal: Objective assessment of the methodological quality, relevance and contribution of the titles selected.
  • Extraction: Structured data collection from selected studies (post appraisal).
  • Analysis: Interpret and summarize the findings to support your regulatory file.

Methodology: MEDDEV 2.7/1 Rev. 4, PICO Framework, PRISMA

Our protocols strictly follow the best international practices:

  • MEDDEV 2.7/1 Rev. 4: Ensures objective and reproducible selection and appraisal of clinical data.
  • PICO (Patient, Intervention, Comparison, Outcome): Structures the search question for maximum relevance and focus of the search terms.
  • PRISMA reporting: Ensures transparent and complete reporting of the search.

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    Why BioTop Medical?

    Expert guidance through complex compliance processe

    Questions? Contact us

    For direct contact call
    +31 (0)71 528 01 12

    You can also email us
    info@biotopmedical.nl

    Services

    For direct contact call
    +31 (0)71 528 01 12

    Questions? Contact us
    info@biotopmedical.nl

    FAQ about Systematic literature search

    How can BioTop Medical do a systematic literature search for a device they did not develop themselves?

    BioTop Medical brings the expertise to perform systematic literature searches along with a team who has a scientific background. Once the client has provided BioTop Medical with the relevant information about their device, we can proceed with the systematic literature search. Typically, the client will explain their device on site, or over a TEAMS session which ever is more appropriate.

    How long does a systematic literature search take?

    The time needed for a literature search (including reporting) depends mainly on the amount of published literature, the period to be covered by the search, and the complexity of the articles. It is not possible to accurately predict the time needed for a search before starting the search. Following the initial raw search, we can provide a more precise estimate. Based on our experience, literature searches typically take between 4 and 55 days of work, with the majority falling within the lower half of this range.

    How do you define the search terms for a systematic literature search?

    For the scientific literature, we typically use the PICO framework.  In conjunction with the client, we define a research question, from which the search terms are derived. For other types of literature (e.g. standards, vigilance) the terms can be defined for example by using the technology, the materials used, brand names etc.

    Who needs to perform the systematic literature search?

    Manufacturers of medical devices who need to provide as much unbiased data/ information as possible, from the literature, to support the safety and performance of a device or to determine the status of the state-of-the art in a specific field, will need to perform systematic literature searches.

    What makes a literature search systematic?

    A literature search is considered systematic when it is performed using a structured / planned approach to identify, select, appraise and extract the data from the literature. The strategy should be clearly documented in detail, to be transparent and reproducible.  The objective is to capture as much relevant information as possible, in an objective / unbiased fashion.