Loved it to
Our package with Formly is exactly what we wanted and what we needed — no BS, no fluff. Formly's services are straight to the point and the team is so pleasant to work with. As a small business and a startup, that’s what you really need.
It depends on your medical device. Class III devices have more extensive regulatory requirements than Class I devices and often take longer to prepare for market entry. Also, notified body audits often take anywhere from 3-12 months to occur. As such, Class I software medical devices can take as little as days to months and Class IIA hardware medical devices can take months to years.
Yes! Formly’s software is built for everyone. If you are unfamiliar with the medical device regulations or wishing to improve your workflow efficiency to get CE marked faster and easier, our software can help. Our Document Autopilot generates MDR compliant documents for you and built in descriptions and video walk-throughs guide you through the rest.
CE is an abbreviation of "conformité européenne" which equates to European conformity. CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. CE marking is especially important for medical devices which must meet a high regulatory standard before being allowed on the market.
You can’t be too early but you can be late. Once you understand what product you want to build, you can start your certification journey. The regulatory processes and records created while preparing for your CE mark integrate with product design, development, and testing. By starting your certification procedures early, you integrate quality processes into your workflow and avoid having to repeat steps down the road.