Price: $1000
This template provides a structured framework for demonstrating the safety and performance of your medical device, aligning with the guidelines outlined in MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation (MDR) 2017/745. This document encompasses a thorough process that includes:
1. Identification of safety and performance requirements supported by scientific literature.
2. Specification of the device’s intended purpose, indications, and contraindications.
3. Definition of parameters for benefit-risk analysis to assess the device’s clinical utility.
4. Determination of outcomes related to clinical benefits and efficacy.
5. Outline of methods for assessing clinical safety, including the identification of residual risks and potential side effects.
6. Provision of a clinical development plan for further investigations and validation.
This template is written by highly experienced professionals for all medical device companies. Click the link below for a preview and elevate your approach to regulatory compliance and clinical evaluation.
