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We are a ISO13485 certified European medical device firm producing and marketing portable electromechanical devices. Our products are CE marked. We would like to investigate the feasibility of registering and marketing our products in the US and to estimate the cost and effort that will be required for the registration. Our main concern is the embedded software that has been developed over last 15 years and may require reengineering to match the FDA requirements.
Does anyone have experience on FDA approval projects for devices (classII and above) of which the software has started to be developed when the current software development standards (e.g. IEC 62304) did not exist? What are the options available? Do we need to develop everything from scratch? Our products are operating on the field with no issues for years..
It is difficult to estimate how much refactoring will be required to meet the FDA requirements and I would really appreciate if any professional with experience on this area could provide us consultancy servrices on this.
Does anyone have experience on FDA approval projects for devices (classII and above) of which the software has started to be developed when the current software development standards (e.g. IEC 62304) did not exist? What are the options available? Do we need to develop everything from scratch? Our products are operating on the field with no issues for years..
It is difficult to estimate how much refactoring will be required to meet the FDA requirements and I would really appreciate if any professional with experience on this area could provide us consultancy servrices on this.