Price: $1000
“This template offers comprehensive information regarding the safety and performance of your medical device, meticulously aligning with MEDDEV 2.7/1 Rev. 4, directives 93/42/EEC and 90/385/EEC, MDCG 2020-13, and EU Medical Device Regulation (MDR) 2017/745. This document serves as a source of evidence, providing:
1. Results of literature reviews, offering insights into existing scientific knowledge and data.
2. Performance testing outcomes, demonstrating the device’s functionality and efficacy.
3. Clinical safety data, outlining the device’s safety profile based on clinical studies and trials.
4. Post Market Surveillance (PMS) data, showcasing real-world performance and safety feedback.
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.”
