Advancing Medtech Innovation with Quality, Compliance, and Speed
The medtech industry demands continuous innovation while navigating complex regulatory requirements and maintaining the highest standards of quality and patient safety. ALTEN Technology supports medical device and diagnostic companies with engineering expertise aligned to FDA regulations and ISO 13485 standards. Our teams help streamline development, strengthen design controls and validation, reduce risk, and accelerate time-to-market—enabling organizations to deliver safe, effective, and compliant products with confidence.
At ALTEN Technology, we provide specialized engineering and consulting expertise to help you overcome these hurdles and turn ambitious concepts into market-ready medical devices. We can support early-stage research and feasibility projects by providing expert engineering, design, and development resources that help de-risk novel, new, or next-generation medtech technologies through rigorous technical assessments, proof-of-concept prototypes, and early verification testing to identify and address potential challenges before full-scale development.
Our team possesses deep domain knowledge across the entire product lifecycle, from initial conceptualization and risk analysis through to production planning to your 510(k) submission. We have extensive experience with complex class II electromechanical medical devices, ranging from low-cost, disposable wearables to sophisticated, free-standing diagnostic instruments.
Our Comprehensive Medtech Engineering Services
We offer a full suite of end-to-end solutions designed to meet your specific project goals while identifying and mitigating risk at every stage. Beyond design and development, ALTEN Technologies USA can also support your ongoing sustaining engineering needs – keeping fielded products relevant and up to date by managing EOL/OBS components, SW updates, and even root-cause and solution implementation of field issues.
Medical Device Design & Development Consulting
Our engineers are specialists in innovative medical device design and engineering. We offer comprehensive consulting to guide you through every stage of product development, including requirements definition, systems engineering, prototyping, and full verification and validation (V&V). We focus on creating robust and user-centric devices that meet both clinical needs and business objectives.
Medical Device Software Development (IEC 62304)
Our software engineers have extensive experience developing compliant software as medical devices (SaMD), including embedded systems, mobile health apps, and secure cloud-based platforms. We ensure your software is reliable, secure, and fully compliant with industry standards like IEC 62304, HIPAA, and cybersecurity best practices.
Medical Device Quality Assurance & Regulatory Compliance
We help you navigate the intricate regulatory environment with confidence. Our quality assurance expertise ensures your products meet the highest safety and quality standards. We provide hands-on support for compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR/IVDR regulations, streamlining your path to market approval.
Medical Device Risk Management (ISO 14971)
A proactive approach to risk is critical. We help you identify, assess, and mitigate risks throughout the entire product development process in accordance with ISO 14971. Our rigorous medical device risk management expertise ensures patient safety, minimizes potential liabilities, and strengthens your regulatory submissions.
Areas of Expertise
- Disposables/Consumables
- Imaging Systems
- Sample Handling
- Automation
- Molecular Diagnostics
- Point of Care Diagnostics
- Cardiovascular & Neurological Diagnostics
- Flow Cytometry
- Bioreactors and Cell Therapy
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