Design and Development
When a medical device needs to be designed and developed it is favorable to follow a certain structured approach. By following a Product Development Cycle (PDC) and Design Control process it is guaranteed that all necessary regulatory steps are taken. The produced documentation output ensures the compilation of a Design History File (DHF). The information collected in the DHF can be used to compile the Technical Dossier to be submitted for European market approval. MDProject has set up a structure to minimize the amount of paper work but fulfill all the regulatory requirements needed for submissions by using the harmonized submission STED format (Summary Technical Document).
Product Development Cycle
The Product Development Cycle (PDC) consists of 4-5 integrated product phases. Prior to the start of a phase, the necessary actions and deliverables are to be documented in detail, timelines are set and milestones determined. The PDC is divided into several phases, to be closed off by a review meeting including a go/no-go decision. The goal of each phase review is to establish the relevant information necessary to make the decision to proceed or not to proceed to the next phase of the development cycle. The compilation of the phases leads to a successful product development program that optimizes a product’s time to market, cost, performance, quality, customer satisfaction, and risk management.
These phases are:
– the concept phase
– the commitment phase
– the development phase
– the transfer phase
– the market surveillance phase
Depending on the amount of time and information available, the concept and commitment phases are sometimes merged into one phase.
Design History File
The intention of a DHF is to document the design history of a medical device starting with a device idea/concept and ending with a marketed device. The setup for this specific project is to provide a structured project approach to guarantee that all necessary steps have been taken to come to a final device ready for the market.
MDProject uses a project approach model to built up the design history of a product. The model requires input and commitment from various disciplines and follows the product development cycle. For each phase in the DHF product development cycle, deliverables are set focusing on specific requirements needed to be able to come to a smooth product registration and market approval.
The Summary Technical Document (STED) is a harmonized submission format developed by the Global Harmonization Task Force (GHTF). The GHTF is a cooperation between representatives from the United States of America and four other member states: European Union, Canada, Australia, and Japan. The GHTF promotes international harmonization of medical device regulation through the preparation and distribution of guidelines. The STED harmonized submission format is already accepted by multiple regulatory authorities worldwide.
The STED format and content is described in the document titled, “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices”, and can be found on the website of the GHTF (http://www.ghtf.org/).