Medical device certification is required to ensure that products meet safety and regulatory standards in the EU and US markets. It involves CE marking for the EU and FDA approval for the US, ensuring products are safe for market entry.

Certification involves determining product risk class, establishing a QMS, creating technical documentation, undergoing audits, and maintaining post-market requirements. Formly assists with all these steps.

Formly covers all major standards including EU MDR 2017/745, ISO 13485, ISO 14971, and US FDA 21 CFR requirements, ensuring compliance in both markets.

Yes, Formly is designed for users at all levels of knowledge. The platform provides AI-generated documents, descriptions, and video walk-throughs for guidance.

Starting early is beneficial. Once product development begins, aligning with regulatory processes helps integrate quality into the workflow, avoiding redundancy later.

Yes, it is possible to start with Class I and later transition to a higher class. Details are available in Formly's blog posts.

The timeline varies by device class and requirements. Class I devices take days to months, Class II devices take months to years, and Class III devices take multiple years.

AI Act rules apply based on device use and compliance with ethical standards. High-risk devices will face regulation beginning in 2024, with gradual enforcement through 2027.

Formly integrates various international standards like ISO 13485, ISO 14971, IEC 62366, and more, ensuring comprehensive compliance for worldwide markets.

Formly’s platform includes features for change management and post-market surveillance, ensuring all regulatory requirements are monitored and met continuously.