Aaron Joseph helps clients navigate
through rigorous regulatory compliance
Understands rapid development of complex, software-intensive medical devices
Uses lean and agile methods to accelerate development of innovative medical devices
“I worked with Aaron on several consulting projects, advising and training product teams, both with and without medical device experience. Aaron’s combination of patience, broad industry knowledge, and ability to break regulatory requirements down into practical instructions makes him an effective advisor and trainer. He is a pleasure to work with and I highly recommend Aaron as a software medical device consultant!“
Grace Kao Li
Head of Quality Verily Life Sciences
“Aaron is excellent to work with and has been invaluable for the team’s success. He has consistently identified issues and provided recommendations for resolving technical, process and regulatory challenges. Aaron is technically competent and is able to lead a cross functional group to resolution. Aaron is who I would call on to streamline technical or regulatory processes. His experience in the industry and the number of projects provides invaluable insights to any med tech start up.”
Molly Saxelby
Managing Principal Systems Engineering at Verb Surgical
Aaron Joseph developed our quality system procedures and DHF documentation in preparation for an FDA 510k filing. He came in on time and under budget for his services and was a valuable addition to the team. He has a pleasant, relaxed demeanor, always responded quickly to pressing requests (especially iterative review requests from the FDA) and is very knowledgeable about systems integration and software. I would recommend him without any reservation and look forward to working with him again.”
Evan Anderson
CEO at Luma Therapeutics
Smooth sailing with better medical device development
Key areas of consulting for new product development:
- Risk management and design controls
- Software design controls
- Efficient management of complex, software-intensive products
- V&V testing
- Requirements management
- Software validation
Efficient and rigorous compliance with FDA QSR (21 CFR 820), IEC 62304, ISO 14971, IEC 62366, EN 60601-1, and related standards for medical device development.
Latest News & Events
- Newsletter V. 2024 Issue 2
- Featured in MPO Magazine – What Makes Complex Medical Devices Different?
- Newsletter V. 2024 Issue 1 – Embracing Change for Medical Device Excellence
- Re-Entrant Design Controls: Managing Medical Devices That Are Never Finished
- Holiday Greetings from Boston – 2023