POST MARKET CLINICAL FOLLOW UP (PMCF) PLAN – TEMPLATE

The simple, easy to edit Post Market Clinical Follow-Up template is officially available! Buy it now!

$65.00

pmcf-plan

Post Market Clinical Follow-Up Template

The Post Market Clinical Follow-Up (PMCF) is usually compiled at the end of an annual surveillance period and serves as an input into the next update of the clinical evaluation for your medical device. This template covers: – Confirmation of the safety and performance of the device – Identification of, and monitoring previously unknown side-effects and contraindications – Identification and analysis of emergent risks – Ensuring continued acceptability of the benefit-risk ratio – Provision of an overview of the procedure and justifications of PMCF activities covered After purchasing, you will receive a word document that is ready to edit. You will receive a copy of the Post Market Clinical Follow-Up template within 24 hours of payment.

$65.00


Included in your Post Market Clinical Follow-Up template are prompts for:

  • Confirmation of manufacturer’s facility details
  • Revisiting the medical device descriptions, specifications and intended uses
  • Describing activities that will be done post market
  • Provision of rationale for appropriateness of chosen methods
  • Confirmation of safety and performance of the medical device
  • Identification of previously unknown side effects
  • Identification of any known and new contraindications
  • Identification and analysis of emergent risks
  • Identification of possible mis-use / off-label uses
  • Overview of screening procedures used
  • Justifications for sample sizes and study designs
  • Much more!


Purchase your simple easy to edit template of a POST MARKET CLINICAL FOLLOW UP TODAY!

pmcf-plan

Post Market Clinical Follow-Up Template

After purchasing you will receive a word document that is ready to edit. You will receive a copy of the Quality Agreement within 24 hours of payment.

$65.00