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.
Price: $500
Request Regulatory & QMS Templates
Select the templates you need and our team will get back to you with details.
Template Purchase Enquiry
Share your requirements and we'll guide you through the next steps
