DELTA provides you with an overview of the regulatory requirements for medical devices and outlines the initiatives you must take before introducing your medical device safely to the market.
The market for medico products is covering a wide range of different product types from heart rate monitors, scanners to electronic patient journals. The introduction of new technologies combined with the healthcare industry’s demand for intelligent solutions generate an increase in the number of medical devices being introduced to the markets all over the world. Operating in this field is exciting yet full of pitfalls as it is a highly regulated market.
Developing successful medical devices for the global market requires that you have a well-documented and well-described quality management process.
DELTA helps you through the process towards product approval – whether you are new in the market or already have knowledge about the development, production, approval and marketing of medico mechatronic products. We give you answers to questions such as:
- What are the regulatory requirements for my medical device?
- Which markets can I access and which documentation is needed?
- Which technologies (e.g. wireless or sensor technology) can I incorporate in my medical device?
Specifying your idea/product concept. Discover which technology should be incorporated. Writing the specification document you can use in your design phase. Specifying essential requirements and intended use, and support your Product Risk Management process and Risk Assessment etc.
Project management support
Guide you through the Design ControlRequirements. You have quick access to our highly skilled experts – no need for you to build up knowledge which saves you time and minimises your risks. We assist you in the Project Risk Management.
Support you with the Regulatory Strategy and Clinical Documentation Plan. Regularory Plan including overview of country specific rules and regulations. Initial clinical screening of published scientific literature. Documents needed for the approval process.
Various tests of your product e.g. extreme testing. EMC and safety testing in accordance with the technical standard IEC 60601