Cost Effective Compliance Solutions
Medical Devices | In-vitro Diagnostics | Software as a Medical Device (SaMD) | Digital Health | AI/ML Applications
Our ISO 13485 Compliant eQMS, Daedalus compliance path, is a comprehensive ISO 13485 eQMS and compliance system designed to reduce development costs, speed time-to-market and manage risk. Our mission is to transform regulatory compliance from 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 path has at its heart an ISO13485 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 for risk management, usability engineering, software development and clinical evaluations, complete with a comprehensive set of template documents to help you take your innovative ideas to global markets.
Daedalus compliance path is aimed at early stage businesses in medical devices, in-vitro diagnostics, software as a medical device, AI/ML applications and digital heath technologies. 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.
Further details can be found here.
Why implement an ISO 13485 QMS
ISO 13485 is an internationally recognized standard that outlines the requirements for a Quality Management System (QMS) specifically designed for medical device manufacturers. It is important for several reasons:
Patient safety: The primary goal of ISO 13485 is to ensure the safety and effectiveness of medical devices. A QMS based on this standard helps manufacturers establish and maintain a systematic approach to design, development, production, and distribution, which ultimately leads to safer products for patients.
Regulatory compliance: Many countries require medical device manufacturers to comply with ISO 13485 as a precondition for market access. Compliance with this standard demonstrates that a company has a robust QMS in place, which can facilitate the approval process with regulatory authorities.
Risk management: ISO 13485 emphasizes risk management throughout the product lifecycle. By identifying and mitigating potential risks, manufacturers can reduce the likelihood of product failures, recalls, or adverse events, which can harm both patients and the company's reputation.
Continuous improvement: A key aspect of ISO 13485 is the focus on continuous improvement. The standard requires manufacturers to regularly monitor, measure, and analyze their processes and take corrective actions when necessary. This approach drives ongoing improvements in product quality and operational efficiency.
Competitive advantage: Obtaining ISO 13485 certification can provide a competitive advantage for medical device manufacturers. It signals to customers, partners, and regulatory authorities that the company is committed to quality and safety, which can help build trust and credibility in the marketplace.
Global harmonization: ISO 13485 is recognized and accepted worldwide, which can facilitate international trade and collaboration. By adhering to a single, globally recognized standard, medical device manufacturers can streamline their operations and reduce the complexity associated with meeting multiple regulatory requirements across different countries.
Overall, an ISO 13485 QMS is crucial for medical device manufacturers to ensure product safety, meet regulatory requirements, manage risks, drive continuous improvement, and enhance their competitive position in the global market.
What is included?
To help you comply with ISO 13485, and regulation in the EU, US and other markets, UOVO medtech have developed Daedalus compliance path:
"As a seed-stage start-up commercialising an innovative cloud-based SaMD for calculating coronary inflammatory burden, UOVO helped us rapidly implement a QMS that not only helped us with our first 510(k) filing and 13485 certification but also efficiently supported our CI/CD-based development practices."
- David Schottlander, Product Manager, Google Health
