Medical Device Clinical Investigation Report

$49.00
$49.00
Unavailable
per item

The Clinical Investigation Report complies with the requirements of ISO 14155:2020. The report provides an excellent structure for summarizing the clinical investigation plan, communicating results of the investigation and overall conclusions.

  • ISO 14155:2020 Compliant
  • MDR 2017/745 Compliant
  • MS Word Format
  • Instant Download - Digital Content
SKU:

Clinical Investigation Report

​The Clinical Investigation Report complies with the requirements of ISO 14155:2020. The report provides an excellent structure for summarizing the clinical investigation plan, communicating results of the investigation and overall conclusions.

Clinical Investigation Report - Compliance

The Clinical Investigation Report complies with MDR 2017/745 and ISO 14155:2020
Clinical Investigation Report
Clinical Investigation Report

Customer's also viewed

Clinical Investigation Procedure

$199.00
The Clinical Investigation Procedure complies with ISO 14155:2020. The Clinical Investigation procedure includes detailed information on all aspects of clinical investigations. The product includes a CIP protocol and report template, Investigators' brochure (IB) template, investigation site initiation and monitoring forms, informed consent template and guidance on CRF construction.
  • ISO 14155:2020 Compliant
  • MDR EU 2017/745 Compliant
  • ​ISO 13485:2016 Compliant
  • Includes Multiple Forms
  • ​MS Word Format
  • ​Instant Download Digital File
VIEW

Clinical Evaluation Procedure

$149.00

The Clinical Evaluation Procedure governs the entire clinical evaluation process from scope definition through Clinical Evaluation Report (CER).The MEDDEV 2.7/1 Rev 4 compliant Clinical Evaluation Procedure also governs Post Market Clinical Follow-up (PMCF).

  • MEDDEV 2.7/1 Rev 4 Compliant
  • MDR (EU) 2017/745 Compliant
  • ​ISO 13485:2016 Compliant
  • MS Word Format
  • ​Instant Download Digital Content
VIEW

Medical Device Clinical Investigation Plan

$49.00

The Clinical Investigation Plan (CIP) complies with ISO 14155:2020. Robust 28 page user friendly form addresses each required clinical investigation plan element defined in ISO 14155 and MDR 2017/745.

  • ISO 14155:2020 Compliant
  • MDR 2017/745 Compliant
  • MS Word Format
  • Instant Download - Digital Product
VIEW

Medical Device Quality Management System | MANUFACTURING PLUS

$3,599.00

The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!​

  • Quality Management System Manual
  • 72 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
VIEW
Copyright © 2010-2024
  •