During the development of your technical file, a regulatory gap analysis is a great way to identify any information that you still need to include to show conformance with the relevant regulations. At Patient Guard Ltd, in Blackpool, Lancashire, we are on hand to complete the analysis on your medical device’s technical file. The process starts with a review that is then followed by a report showing where the gaps may be. The analysis is a vital tool in understanding your budget requirements and the timeframe in becoming compliant.
Failure to understand what information may be missing from your technical file could cost you in the long run and potentially cause your company serious harm. In the worst situations, a lack of understanding may lead to failed audits and even action being taken by the competent authorities in the form of field safety notices, medical device alerts, or even withdrawal of the CE mark and removal of your product from the market.