Formly: Revolutionizing Medical Device Certification
In the complex world of medical device certification, Formly emerges as a leading platform that simplifies and accelerates the process. With its combination of expert regulatory guidance and AI-backed features, it offers a comprehensive solution for startups and businesses aiming to certify their medical devices in the EU and US.
Key Features
AI Backed Documentation Writing
Formly's AI copilot enables effortless creation of audit-proof technical documentation. It takes the stress out of wording and interpreting standards and guidance documents, allowing users to build documentation that meets the highest regulatory standards with just a push of a button. This AI-generated documentation is MDR compliant, saving users significant time and effort that would otherwise be spent on manual drafting.
Quality Management System (QMS)
The platform allows users to create a fully ISO 13485 compliant QMS within minutes. Gone are the days of spending thousands on templates and workshops. Formly provides a ready-to-use QMS that streamlines document approval and lifecycle management, ensuring seamless compliance with regulatory requirements.
eQMS for Document Management
The built-in eQMS makes it easy to manage document approval and revisions. It comes with all the necessary features to handle the documentation needs of medical device certification, ensuring that all documents are in order and can be easily exported whenever needed. There's no vendor lock-in, giving users full control over their data.
Use Cases
Startups and Small Businesses
For startups like those in the medical device field, getting to market quickly while ensuring compliance is crucial. Formly's services are tailored to meet these needs. It provides the necessary regulatory guidance along with the software tools to handle EU and US medical device compliance. This allows startups to focus on their go-to-market strategies rather than getting bogged down in compliance hell.
Established Companies
Even established companies can benefit from Formly's streamlined processes. Whether it's handling changes in device classification, managing post-market surveillance, or ensuring continuous compliance with evolving regulatory requirements, Formly offers a one-stop solution. Its ability to scale with different market sizes, team sizes, and budget constraints makes it a versatile choice for companies of all scales.
Pricing
Formly offers different pricing plans to suit various needs:
Premium Plan (299€/month)
This plan includes everything needed to certify one device from start to finish. It covers all technical documentation requirements such as ISO 14971, IEC 62304, IEC 62366 and more. The QMS is compliant with ISO 13485, and there's streamlined document approval and lifecycle management. Users also get one-click technical file generation ready for notified body submission, along with weekly 1:1 sessions with regulatory experts for guidance and progress validation. They can export their documents at any time, and the documentation is checked by CE Audit experts.
Premium+ Plan (699€/month)
Similar to the Premium plan but with the added benefit of regulatory expert assistance. This plan is ideal for those who need more hands-on guidance during the certification process.
Full Service Plan (24,999€)
For those who want a completely hands-off approach, the Full Service plan does everything for the user. From start to finish, it takes care of certifying the device, including all the technical documentation, QMS management, and expert guidance.
Comparisons
When compared to traditional methods of medical device certification, Formly stands out in several ways. Traditional approaches often involve spending a significant amount of time and money on hiring external consultants, purchasing templates, and attending workshops. Formly, on the other hand, combines the expertise of its regulatory team with AI-powered tools to offer a more efficient and cost-effective solution.
Compared to other software platforms in the market, Formly's unique selling point is its integration of AI in documentation writing and its comprehensive suite of features that cover all aspects of medical device compliance, from technical documentation to regulatory guidance.
Advanced Tips
Stay Agile
Formly enables users to stay agile in the certification process. With its rapid iteration capabilities, users can keep fast release cycles and not get stuck after their device is certified. This allows for continuous improvement and adaptation to changing regulatory requirements.
Monitor Progress
The platform provides clear steps to success and allows users to monitor their progress. By focusing on what work should happen next, users can maintain velocity and make meaningful progress towards successful certification.
In conclusion, Formly is a game-changer in the field of medical device certification. Its combination of AI and expert guidance offers a powerful solution for businesses looking to navigate the complex regulatory landscape with ease and speed.
