Formly: Your AI-Powered Ally for Swift Medical Device Certification

Formly

Formly simplifies medical device certification in the EU and US. With AI-backed docs and expert guidance, it helps businesses get to market fast, on budget, and compliant with all relevant standards.
Formly: Your AI-Powered Ally for Swift Medical Device Certification

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.

Featured AI Tools

Ask Mama.ai

Ask Mama.ai

Ask Mama.ai is an AI-powered parenting assistant that offers personalized support 24/7.

Physician UX

Physician UX

Physician UX is an AI-powered platform that helps healthcare providers save time and focus on patient care.

Wendy Labs

Wendy Labs

Wendy Labs is a Clinical AI that helps mental health providers streamline costs and empower patients with personalized support.

Sunoh.ai

Sunoh.ai

Sunoh.ai is an AI-powered medical scribe that helps physicians save time and improve clinical documentation.

Lyrebird Health

Lyrebird Health

Lyrebird Health is an AI medical scribe that automates clinical documentation, saving clinicians' time.

basebox

basebox

basebox is an AI-powered platform for healthcare, offering secure and efficient solutions.

Clinicminds

Clinicminds

Clinicminds is an AI-powered clinic management software that streamlines operations.

Sully.ai

Sully.ai is an AI-powered solution that assists in various healthcare tasks, saving costs and improving efficiency.

PMcardio

PMcardio

PMcardio is an AI-powered medical device that accurately diagnoses cardiovascular diseases in seconds from your smartphone.

Freed

Freed

Freed is an AI medical scribe that saves clinicians time and simplifies note-taking.

Limbic

Limbic

Limbic is an AI-powered clinical assistant that enhances mental healthcare, improving patient outcomes.

Kareo

Kareo

Kareo is an AI-powered medical software that simplifies practice management for independent practitioners.

VetRec

VetRec

VetRec is an AI-powered clinical assistant for veterinarians, streamlining SOAP notes.

Intelligencia AI

Intelligencia AI is an AI-powered clinical assistant that de-risks drug development.

Zephyr AI

Zephyr AI

Zephyr AI is an AI-powered clinical assistant that enhances healthcare outcomes.

Aidoc

Aidoc

Aidoc is a clinical AI company that enhances healthcare with advanced solutions.

S10.AI

S10.AI

S10.AI is an AI-powered medical scribe that simplifies documentation and boosts efficiency

Scribeberry

Scribeberry

Scribeberry is an AI-powered medical scribe tool that saves time for healthcare pros

Azyri

Azyri

Azyri is an AI-powered medical assistant that offers accurate diagnoses and accessible healthcare.

Ada Health

Ada Health

Ada Health is an AI-powered clinical assistant that improves health outcomes