MakroCare offers Scientific Literature search solutions as part of the medical device & diagnostic clinical (CER/PER) and Biopharma services. Our clinical regulatory staff hasexperience in searching for articles from multiple databases published and can comprehensively manage your literature screening requirement in a cost-effective manner applying required scientific and regulatory rigor and provide the required summary reports.
MakroCare literature specialist team has deep experience in scientific, technical, clinical & medical fields; We work closely with customers on one-on-engagement model and develop the search strategy methodology to ensure that criteria are robust and compliant with any regulatory specific requirements. We perform the literature search be for aggregate reports, or benefit-risk analyses or for signal evaluation or ongoing screening as required by local and regional requirement.
When and why is a Literature Search Needed?
Although literature searches are commonly done as part of a device’s clinical evaluation, manufacturers should use them to obtain information throughout its entire life cycle. In agreement, the MDR mentions literature searches as a source of information in the pre-clinical evaluation, clinical evaluation, and post-market surveillance phases:
| Stage of Medical Device Life Cycle | Literature Search | Purpose of the Literature Search |
|---|---|---|
| Pre-clinical Evaluation | Pre-clinical Literature Search Annex VII, Section 4.5.4 | Obtain information for the pre-clinical evaluation of the device |
| Clinical investigation | Background literature review Annex XV, Section 3.2 | Establish the State-Of-The-Art (SOTA), available treatment options and proposed benefits of a new device, establish the sample size of the investigation |
| Clinical Evaluation | Systematic Scientific Literature Search Annex VII, Section 4.5.5 Annex XIV, part A, Section 1 (b) | Identify ‘clinical data’ concerning the safety or performance of a device for which equivalence to the device in question can be demonstrated |
| Surveillance activities and post-certification monitoring | Screening of scientific literature Annex III, Section 1.1, (a) Annex VII, Section 4.10 Annex XIV, part B, Section 6.2 (a) | Obtain clinical literature relevant to the condition being treated with the device or obtain literature relevant to similar devices |
We can also help companies update literature review of a legacy device to an MDR / IVDR compliant document. Our medical writers can perform MDD to MDR gap assessments, provide guidance to complete a literature search and review transition from MDD or MEDDEV 2.7/1 revision 4 to the new MDR, and develop required documentation adapted to your needs. Applying similar process for IVDR, we provide literature and scientific validity needed for PER reports.
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