Formly: Simplifying Medical Device Certification
Overview
Formly is a revolutionary platform that focuses on making medical device certification a breeze. It caters to startups and businesses of all sizes, ensuring they can meet the regulatory requirements in the EU and US without breaking the bank or getting bogged down in complex paperwork.
With its combination of an expert regulatory team and AI-backed documentation writing, Formly offers a comprehensive solution for getting medical devices to market fast and on budget.
Core Features
- MDR Classification Tool: Trusted by next-gen companies, this tool aids in accurately classifying medical devices according to the relevant regulations.
- Quality Management System (QMS): Users can create a fully ISO 13485 compliant QMS within minutes, eliminating the need to spend thousands on templates and workshops.
- Technical Documentation: The AI copilot simplifies the process of building audit-proof documentation. It takes the stress out of wording and interpreting standards and guidance documents.
- eQMS: The software comes with built-in features to easily manage document approval and revisions, ensuring smooth operations throughout the certification process.
Basic Usage
Getting started with Formly is straightforward. Newcomers can begin with the free trial and avail of the free expert guidance. Once on board, they can utilize the various tools and features based on their specific needs.
For example, if creating technical documentation is the priority, the AI copilot will assist in effortlessly generating the required documents that are compliant with regulations like MDR 2017/745 and US FDA 21 CFR, along with other relevant standards such as ISO 14971, IEC 62304, and IEC 62366.
Compared to traditional methods of medical device certification that involve extensive manual work and high costs, Formly stands out by automating tedious tasks and providing clear roadmaps and guidance. It truly is a game-changer in the medical device compliance landscape.
