When it comes to developing medical devices there are several plans that you can plan on. The second phase of our Product Development Process (See previous blog, Link) is the Planning Phase. We use this stage of the PDP to help our customers establish that all important "Guidance Documents". We rely on a trio of planning document to establish the roadmap to market. These documents are the Quality Plan, Design Plan, and the Risk Management Plan.
It is tempting to think that establishing these documents only delays the development process. We have found that, if done right, these documents can ultimately lead to a shorter time to market by defining clear roles and responsibilities, design strategy and priorities, and ground rules for risk mitigation activities. These documents also outline how the FDA Design Control regulations will be satisfied.
At PADT Medical, we help our customers establish these documents in accordance with your business and product development objectives. We have existing protocols and templates that we can draw from to streamline the planning process and help you take your product to market in a controlled and well-planned process.
