Our Certifications
QuickBird Medical develops healthcare software in accordance with the leading international standards in Europe and the USA. An overview of our certifications and relevant standards and laws can be found here.
Certifications
ISO 13485 certified
Our quality management system is certified according to ISO 13485. This enables us to ensure the necessary quality of medical device software both under MDR and in accordance with the requirements of the FDA Quality System Regulation (21 CFR Part 820).
ISO 27001 certified
QuickBird Medical is certified according to ISO/IEC 27001 for information security. We are experts in the areas of cybersecurity and health data protection. This certification also enables us to assume the role of legal manufacturer for DiGA, among other things.
EU: Standards & Laws for Medical Device Software
QuickBird Medical operates in compliance with the following standards and laws for the development of software medical devices in the EU.
MDR
The Medical Device Regulation (MDR) is the legal basis for the approval of medical devices in the EU. We develop software in such a way that it complies with the strict requirements of the legislation.
ISO 14971
This standard defines the process for risk management in medical devices. We systematically identify, evaluate, and minimize risks in order to develop safe software solutions.
IEC 62304
This standard specifies requirements for the entire development life cycle of medical device software. From planning to maintenance, we ensure the quality of software development.
IEC 62366-1
IEC 62366-1 defines methods for ensuring the usability of medical devices. The standard establishes framework conditions for identifying and mitigating usability risks.
IEC 81001-5-1
This standard addresses cybersecurity for healthcare software and is used by many notified bodies during testing. We work in compliance with the standard to meet the necessary data security standards for medical device software.
IEC 82304-1
IEC 82304-1 specifies safety requirements specifically for health software. It fits into our software development life cycle according to IEC 62304.
USA: Norms & Standards for Medical Device Software
QuickBird Medical operates in compliance with the following standards for the development of software medical devices in the United States. The FDA guidelines form the basis for our development processes.
SOC 2 Compliance
SOC 2 is a standard for data management based on Trust Service Principles. We develop software according to these principles for security, availability, and confidentiality.
HIPAA & HITECH Compliance
HIPAA & HITECH define strict requirements for the protection of patient data in the USA. We ensure that our software solutions meet these security and data protection requirements.
FDA 21 CFR Part 11
This regulation governs how electronic records and signatures are used in a legally compliant manner. Our systems meet these requirements, thereby guaranteeing integrity and security.
FDA 21 CFR Part 820 (QMSR)
Part 820 is the FDA’s Quality Management System Regulation (QMSR). It defines requirements for the quality management system for the manufacture of medical devices.
Are you planning to implement medical software
or DiGA?
Contact us for a free initial consultation. We will give you an estimate of the effort and timeframe required to implement your project. We will also examine the regulatory and strategic framework conditions for your product.