Beyond compliance: a cost-effective ISO 13485 eQMS to drive your journey from idea to success story

A comprehensive ISO 13485 eQMS and global compliance system designed to reduce development costs, speed time-to-market and manage risk.

Medical Devices | In-vitro Diagnostics | Software as a Medical Device | Artificial Intelligence

Our mission is to transform regulatory compliance from being considered a roadblock hindering innovative medtech entrepreneurs into a gateway to global market access. We do this by providing a highly cost effective cloud hosted solution designed to guide early stage medtech businesses through the maze of regulation and international standards with clarity and efficiency.

Daedalus compliance has at its heart an ISO 13485 compliant eQMS, built on a state-of-the-art digital document management system which is fully aligned with FDA requirements for electronic signatures, version control and audit traceability. But it is much more than that. It incorporates a comprehensive set of processes and procedures needed for regulatory compliance in the US, EU, UK and MDSAP countries. In addition, you'll receive fully compliant procedures to guide you through risk management (ISO 14971), usability engineering (IEC 62366), software development (IEC 82304, IEC 62304) and clinical evaluations (ISO 14155 for medical devices, and ISO 20916 for IVDs), complete with a comprehensive set of template documents to help you take your innovative ideas to global markets.

Daedalus compliance is aimed at early stage businesses in medical devices, in-vitro diagnostics, software as a medical device, AI/ML applications and digital heath technologies. For established businesses, we can offer a migration of your existing QMS to our platform.

We aim to help you achieve the certifications you need, in a highly cost effective package, so that you can focus on developing winning technology.

Our Clients

Redefining eQMS Standards: The Daedalus Distinction.

When evaluating an eQMS provider ask these questions: Does your eQMS provide a risk management procedure and templates for a risk management plan, hazard analysis, FMEA and risk management report? Does your eQMS include procedures for software development including both linear and agile methodologies and a comprehensive set of templates? Does your eQMS include procedures for usability engineering? Does your eQMS provide a robust set of processes and procedures adapted to suit the needs of AI development?

With Daedalus Compliance, the answer is YES.

Daedalus Compliance isn't just another eQMS—it's represents the culmination of over three decades’ high-level experience in the sector. Our founder's pedigree includes developing some of the most sophisticated medical devices in existence working as an engineer, R&D leader and Director with a multinational medical devices business. He has held several senior positions in medtech start-ups so has first hand experience of the challenges faced.

As a consultant he has guided many new ventures to ISO 13485 certification, CE marked devices and 510(k) clearances with a 100% track record.

With an MSc in Computer Science, training from the prestigious MIT, and credentials as an ISO 13485 lead auditor and technical documentation assessor with a Notified Body, you're not just getting a system crafted by a compliance expert; you're investing in a legacy of excellence and unparalleled expertise.

How it works

Daedalus compliance is built on a leading digital document management system from Cognidox, a Cambridge based software business.

Cognidox is a leading and cost effective provider of eQMS solutions to the Life Science market. Built on 15 years of eDMS core functionality, Cognidox provides world class documentation traceability, design control, technical files submission and a host of quality modules that provide the backbone to your ISO and/or compliance FDA requirements.

Cognidox boosts powerful integrations to MS Office and DocuSign as well as a Visio driven graphical front end to flow chart internal procedures and process for the complete life science eQMS.

Cognidox - Core Features

Built on a State-of-the-Art Digital Document Management System

Pricing

We understand the realities of running a start-up, especially the challenge of accomplishing great things on a tight budget. It is for this reason that we have created an eQMS and compliance tool that helps reduce development costs and accelerates time to market.

Crucially, we have priced Daedalus compliance to be affordable for most start-ups, with two options for payment.

In option 1, the initial one-time-only cost is for the Quality Management System which fully addresses the requirements of ISO 13485 and applicable regulatory requirements, including risk management, design control, usability engineering and software development. The ongoing monthly cost is for hosting, maintenance, regular updates based on regulatory intelligence and standard updates and site administration for you.

In option 2, the initial cost is spread over the first 12 months. In this case, there is a minimum 12 month contract. After the first year the monthly costs are identical to option 1 above. It can be seen that Option 1 carries a discount for the upfront payment.

We believe that this is the most cost effective, high-quality, audit ready eQMS on the market.