Resources
Reference material for teams building for India and for export. What is published so far is the map of standards a device programme is measured against.
Insights
How a medical device is classified in IndiaThe Medical Devices Rules, 2017 put every device in one of four risk classes. The class decides who grants the licence and how much evidence you need, so settle it early.India, the US and the EU: three routes to market, side by sideEach market has its own classes, its own regulator and its own route. One design file can serve all three, if it is planned for them from the start.Six standards that shape a device before testing startsMost standards are thought of as test standards. Six of them decide design choices long before a device reaches a lab.Build the design history file as you goISO 13485 asks for a record of each design stage. Written at the stage, it costs little. Compiled at the end, it costs weeks and loses the reasons.Design transfer: from a working prototype to a production lineA device that works on the bench is not yet a device you can make a thousand times. Design transfer is the step that closes that gap.How to write an intended use statementThe intended use is a few sentences, and it governs the class, shapes the risk analysis and limits what you may claim. Write it first, and write it with care.Verification and validation are not the same testVerification asks whether the design was built to its own requirements. Validation asks whether the device meets the need it was made for. A plan needs both, and one cannot stand in for the other.Risk management under ISO 14971, from hazard to controlISO 14971 gives a device team one chain to think along: a hazard leads to a hazardous situation, and a hazardous situation may lead to harm. Risk controls break that chain, and the standard puts them in an order of preference.Software in a medical device: IEC 62304 safety classesIEC 62304 sorts device software into three safety classes. The class follows the worst harm the software can contribute to, and it sets how much lifecycle work you owe. Decide it early, from the risk analysis.Usability engineering with IEC 62366-1Some harmful use errors come from the design of the interface, not from the user. Usability engineering finds the tasks that matter, tests them early, and shows that the final design works for representative users.Planning a biocompatibility evaluation with ISO 10993-1Biocompatibility is not a list of tests to buy. It is an evaluation, planned inside risk management, that starts from what touches the body and for how long, and tests only what existing information cannot answer.
Tools
Readiness checkEight questions on the need, the build and the market. You get a plain verdict on whether to build now, and the three steps that would move it most.Intended useAnswer ten short questions and get an intended use statement you can edit and copy, with the points where your wording commits you to evidence.Class and routeFind the likely risk class of your device under the Medical Devices Rules, 2017, the licence and the form you apply on, the standards that apply and the route step by step.
Where to start
Questions about these resources
Are these articles regulatory advice?
No. They are general guides to the rules and standards. A decision for your device belongs in its regulatory file.
Can I get the text of a standard here?
No. Standards are sold by ISO, IEC and national bodies such as the Bureau of Indian Standards. We explain what they govern, not their text.
See where your device stands
Three free tools that run in your browser and send us nothing: a readiness check, an intended use builder and your likely class and licence.