Price: $500
This template offers comprehensive guidance on the post-market surveillance (PMS) process, aligning with relevant standards and regulations, including Regulation (EU) 2017/745 – Article 83, 84, 85, 86, Section 1.1 of Annex III, ISO/TR 20416:2020, NB-MED-2_12-1_rec1, MDCG 2022-21, MEDDEV 2.12.1 rev. 8, and MDCG 2023-3. It outlines a proactive and systematic process that manufacturers can use to collect and analyze appropriate data for post-market surveillance purposes. It provides guidance on the feedback processes and emphasizes the importance of utilizing this information to meet applicable regulatory requirements and gain insights from post-production activities.
This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.
