The landscape of healthcare technology is constantly evolving with ever-changing norms, standards, and rapid advancements in testing methodologies. These developments, coupled with the increasing complexity of healthcare software and the critical role it plays for patients and healthcare providers, require robust Quality Assurance procedures. Ensuring software reliability, security, and compliance demands significant time, resources, and can lead to inflated costs if not managed efficiently.
At Repado, we specialize in Quality Assurance tailored for the medical field, making us your ideal outsourcing partner. With a comprehensive range of healthcare and medical software testing services, we cover all aspects from functionality to usability and security.
Our dedicated Quality Assurance (QA) team performs thorough end-to-end verification of your software. We adhere strictly to the latest guidelines, best practices, and medical standards such as ISO 13485, IEC 62304, and the General Principles of Software Validation (GPSV). Our testing process includes meticulous code analysis, rigorous unit testing, comprehensive performance evaluation, and exhaustive system testing. This ensures that your software not only meets but exceeds the highest quality standards required for healthcare applications.
Usability and ergonomics are critical for the success of medical software. Following EN IEC 62366 usability standards, our team assesses usability factors to gauge the effectiveness, performance, customer satisfaction, safety, and efficiency of your product. By conducting thorough usability testing, we help optimize user experience and ensure intuitive interaction with your software.
Security and privacy are paramount in healthcare software. Our comprehensive security testing protocols align with industry norms and best practices, including ANSI UL 2900-2-1, BSI-CS 132, IEC 62304, IEC 82304, IEC 80001, HIPAA Security and Privacy Rules, GDPR, and FDA's Management of Cybersecurity in Medical Devices. We rigorously test your software to identify vulnerabilities, ensure data integrity, protect against cyber threats, and maintain compliance with regulatory requirements.
Repado is a certified software development house specialized in the Life Science and Healthcare Industry.
With more than 20 years’ experience in the MedTech field, we provide Software Development and Consultation services for regulated environments (MDR/IVDR).
The company is certified under ISO13485:2016 with primary objective the facilitation of harmonized medical device regulatory requirements for Quality Management Systems and ISO9001:2015 Certification for Software development and Implementation.
email: info@repado.com
