Your Trusted Medtech & Life Sciences Consulting Partner
The medtech and life sciences sector is a dynamic industry where innovation is paramount. Companies face the challenge of navigating complex regulatory landscapes, ensuring product quality and safety, and accelerating time-to-market. ALTEN Technology offers comprehensive medtech consulting services to help you overcome these hurdles.
Our team of experts possesses deep domain knowledge in medical device development, regulatory compliance, and quality assurance. We offer end-to-end solutions, including medical device design consulting, medical device software development, and medical device quality assurance and regulatory compliance.
Our experience working on complex class II electromechanical medical devices ranges from low-cost, disposable wearables to free-standing diagnostic instruments. From conceptualization through transfer to production planning for 510(k), we’re focused on helping you meet your specific goals while identifying and mitigating risk throughout the program and product life cycle.
Our medtech and life sciences consulting services
Medical Device Software Development: Our software engineers have extensive experience developing software for medical devices, including embedded systems, mobile apps, and cloud-based solutions. We ensure your software is reliable, secure, and compliant with industry standards.
Medical Device Design and Development: Our engineers specialize in creating innovative class II electromechanical medical devices. We offer medical device design consulting to guide you through every stage of product development.
Medical Device Quality Assurance and Regulatory Compliance: We help you navigate the complex regulatory environment, ensuring your products meet the highest quality and safety standards. Our medical device quality assurance expertise covers risk management, testing, and compliance with ISO 13485, FDA regulations, and other international standards.
Medical Device Risk Management: We help you identify, assess, and mitigate risks throughout the entire product development process. Our medical device risk management expertise ensures patient safety and minimizes potential liabilities.
