CEO & Co-Founder at FormlyAI | Medtech certification for startups made easy | ex-FDA
1. Regulations are the same for all medical devices EU medical devices are categorized into 4 risk classes: Class I, Class IIa, Class IIb, and Class III. Your device designation is determined by things like invasiveness (is the device implanted?), intended purpose, duration of use, active vs. non-active (meaning
We have big news! FormlyAI now has a new eQMS! And better yet, we have new more affordable pricing. Also, we are excited to announce we have finally released our new electronic Quality Management System (eQMS) that allows you to store and approve your documentation within our Formly software. This
Corrective and Preventive Actions (CAPA) are how you fix issues that have been identified with your medical device. Think of it as a formal way of documenting your problem fixing process. What triggers a CAPA? Issues may come from adverse events, nonconformities, audits, customer complaints, a defective component, or if
In the dynamic landscape of the European Union, funding can make or break success for startups at their earliest stages. Finding sources of non-dilutive or public funding like grants is especially beneficial to those trying to make ends meet. In Particular, startups often grapple with the challenge of securing
Artificial intelligence (AI) is exploding right now, expanding so quickly that regulations have yet to catch up, until now. The growth trajectory of AI has only increased with time, with an expected annual growth rate of 37.3% from 2023 to 2030. The European Commission AI Act (we will call
What is a UDI? The Unique Device Identifier (UDI) system is used for the global identification and tracing of medical devices throughout their lifecycle. Think of a UDI as a barcode - each UDI is a unique assembly of letters and numbers that adhere to a universally recognized standard used to
What is Post-Market Surveillance? Post-market surveillance (PMS) in medical devices is a systematic process that monitors the safety and performance of a medical device after it has been released on the market. After your device goes to market, this ongoing process is used to identify potential safety issues,
Most medical device companies must undergo a conformity assessment (essentially an audit) prescribed by a Notified Body in order to receive a CE marking. This process is required for all medical devices and in vitro diagnostic (IVD) devices except the lowest-risk devices (Class I and Class A, respectively). Thus,
In the world of medical devices, software plays a critical role. However, not all software used in these devices is developed from scratch. Often, off-the-shelf software, or software of unknown provenance (SOUP), is integrated into the device. But what exactly is SOUP? Update: We also released a new
Can I Certify as Class I First and Do Class IIA Later? We have had many clients come to us and ask any variety of the same question: “I think my device will end up being Class IIA but I want to start with it on the market as Class
The Difference Between IVDR and MDR in the EU The European Union's regulatory framework for medical devices can be quite perplexing, especially for startups venturing into the healthcare sector for the first (or even 10th) time. Knowing whether your product falls under In Vitro Diagnostic Regulation (IVDR) 2107/
The path to bringing a medical device to the European Union (EU) market is paved with challenges, chief among them being successfully acquiring a CE mark. The CE mark certification is a passport for your medical device, allowing it to be sold across all EU countries. The CE mark for
