EditverseDevice and diagnostics evidence: CER and PER literature
from $400See levels and order
A clinical evaluation or performance evaluation stands on a documented, reproducible literature search and an appraised review of the state of the art. This service prepares that component. It is for regulatory and clinical affairs teams at medical device and in vitro diagnostic manufacturers, and for consultants compiling a CER or PER for a client.
Specification
- You provide
- The device description, intended purpose and claims, the equivalent or similar devices, existing clinical data, and any earlier search protocol or report.
- We do
- Write the search protocol (questions, databases, strings, limits, selection criteria), run and log the searches, screen records, appraise the included papers and build the state-of-the-art review with evidence tables.
- You receive
- Literature search: search protocol and results log with the retrieved records. Literature review: appraised review with evidence tables, selection flow and reference library file.
- Standard applied
- The clinical evaluation requirements of Regulation (EU) 2017/745 on medical devices and the performance evaluation requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices; PRISMA 2020 for reporting the search and study selection.
- Turnaround
- Literature search: 5 business days. Literature review: 3 to 4 weeks.
- Revision rounds
- 1 round.
- Team
- A medical writer experienced in device literature searching, and a subject-matter expert (MD or PhD in the clinical field of the device).
Levels
The search can be bought alone or as the first stage of the review.
| What is included | Literature search $400 | Literature review $1,500 | Full CER or PER, by quote |
|---|---|---|---|
| Search protocol with questions, databases and strings | |||
| Search results log, dated and reproducible | |||
| Screening against selection criteria with reasons for exclusion | |||
| Appraisal of included papers | |||
| State-of-the-art review with evidence tables | Small review: scope agreed before start | ||
| Analysis of the manufacturer's clinical data and benefit-risk conclusions | |||
| Revision rounds | 1 | 1 | Agreed in the quote |
A full CER or PER quote depends on the device class and novelty, the number of indications and variants, the volume of literature and clinical data, and whether the report is new or an update. For contract research, clinical investigations and product development, see Neucite Consulting through the research consulting page.
How the work is checked
Reproducibility
Each search is logged with database, date, full string and number of records, so a notified body reviewer can rerun it.
Selection record
Inclusion and exclusion decisions are recorded per paper, and the selection flow is reported following PRISMA 2020.
Appraisal
Included papers are appraised for relevance to the device and for methodological quality, using criteria stated in the protocol.
Data check
Entries in the evidence tables are verified against the source papers by a second reviewer.
Editverse Medical work is aligned with COPE, ICMJE and GPP 2022; institutional and country-specific ethics requirements are followed. Authors keep authorship and accountability.
Not included
Regulatory strategy, equivalence demonstration, post-market clinical follow-up plans, risk management files and notified body correspondence are outside this service.
Ordering and payment
Both priced levels can be ordered and paid for by invoice. Manufacturers who prefer to assess the work first can press Request this service, send the device description, and pay after the first draft is delivered, only if it meets expectations. An official invoice and receipt are issued, and full reports are by quote.
Questions about this service
Which databases are searched?
The databases are named in the search protocol and agreed with you before the search is run. The choice follows the device and the clinical field.
Can the search be rerun for the next update?
Yes. The protocol and strings are delivered so that the same search can be repeated with a new date range at each update.
What does a small review mean at the Literature review level?
A review on one device and one intended purpose, with scope and expected number of included papers agreed before work starts. Larger reviews are quoted.
Do you write the whole CER or PER?
Yes, by quote. The literature component described here becomes the corresponding sections of the full report.
Part of Corporate medical writing. Related: Systematic Review and Meta-Analysis and Medical Communications.
Order this service
from $400