CE Marking – Writing a MDR-compliant Technincal Documentation and get support to pass the audit from your Notified Body.
Get your device FDA approved by passing through a 510 (k) process or even a PMA
Product Development as described and established Process is integral part of the required Quality Management System in your company. A new R&D project starts with the definition of ALL User Requirements / Customer Needs. This is a must and ‘not written is not done’.
It helps a lot to fix in the very early stage already the Intended Purpose (Mode of Action) and the Indication (Clinical Use) of the new medical device. The proper translation of the User Requirements into Development Specifications (system + separately components) is often a challenge.
The documentation of the Validation and Verification is meanwhile understood but often the statistical background for the test samples is missing. The structure of this process is integral part of the required Technical Documentation accordingly in EU 2017/745 – ANNEX II and III. The clinical related Validation activities of the User Requirements are the starting point of the documentation of your Post Market Surveillance (MDR ANNEX III) and are the current hot topic in the upcoming regulatory requirements. It is wise to have a special focus on the continuous maintenance on this documentation part.
After having the Technical Documentation and Declaration of Conformity in place, the Market Launch and the Post-Market-Surveillance will start in parallel, meaning that the Quality Management System requires a continuous improvement not only for processes, but also for the devices themselves. As a result, the complete Lifecycle Management needs Quality / Regulatory Support to keep your medical devices up to date: Plan-Do-Check-Act well known as the change control process in your Quality Management System.
