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I have been continually impressed with Spencer's Quality and Regulatory expertise. The caliber of industry experience at Formly matched with their incredible software is an unbeatable combo.
We know we have the back office covered with Formly. They are hands on and make our MDR compliance easy. You get a team who provides guidance on best practices in the medical device compliance world, and you spend a fraction of the time you would on this work otherwise.
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.
This all 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. Your development time for creating and testing your product will always depend on your company and product type. Generally, Class I software medical devices can take as little as days to months. Class II (IIa / IIb) medical devices can take months to years, and Class III devices take multiple years.
When it comes to reviewing your certification submission, in the EU, notified body audits often take anywhere from 3-18 months to complete for Class IIA, IIB and III products. In the US under the FDA, the review for 510(k)s take 30-90 days while Premarket Approval (PMA) can take up to 180 days. Typically, 510(k)s are for Class II products and PMAs are for Class III products.
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 certified faster and easier, our software can help. Our Document Autopilot generates MDR and FDA compliant documents for you and built in descriptions and video walk-throughs guide you through the rest.
In the EU, medical device certification is a CE mark for your product. 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.
In the US, medical device certification means approval of your product by the US Food and Drug Administration (FDA). This can be as simple as registration of your device in the FDA database for Class I products, to 510(k) clearance for Class II devices, or PMA for Class III devices. In all cases, medical products like medical devices are under regulatory scrutiny of the FDA and need to satisfy the FDA requirements in order to be sold on the US 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 certification 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.
