About

About 2018-04-20T11:01:12-07:00
compass

Our Philosophy

We believe that rapid agile development of innovative medical devices should not be at the expense of rigorous regulatory compliance. Medical device companies need both in order to succeed in today's healthcare market.

Our Methods

Close collaboration and communication with your team is a priority for all of our projects. We provide:

  • People to directly assist your team
  • Process streamlining to improve product development
  • Tools to automate data management and documentation
Aaron Joseph

Aaron Joseph

Principal Consultant

Aaron has over 20 years of experience in medical device development. He's been involved in over 50 development projects in 26 different quality systems. Aaron's experience covers a wide range of products: surgical robotics system, digital x-ray fluoroscopy system, heart-lung bypass machine, robotic catheter system, x-ray catheter for brachytherapy, laser eye surgery system, endoscopy instruments with RF ablation, and multiple IOT products.

Aaron is an avid promoter of lean and agile methods and helps clients to efficiently comply with regulatory requirements for software and hardware development. He works closely with product development teams in performing risk analyses, developing test plans and protocols, managing product requirements, refining design control procedures, and training R&D staff.  Aaron is an expert at medical device design verification and validation, including software, hardware, and system testing. 

He is able to apply design controls efficiently and rigorously to a broad range of products and adapt them to small and large organizations.

Aaron has a BS in Electrical Engineering from Rice University and a MS in Bioengineering from University of Washington.

Our Partners

We can connect you with additional expertise through our collaboration partners:

Irwin & Associates provides expert consultants in quality engineering, technical writing, manufacturing engineering, and related areas for medical device companies.

Consensia provides software tools for managing complex product development, including the ZipQuality system expressly configured for medical device companies.

Matrix Requirements provides Quality Management System (QMS) and Application Lifecycle Management (ALS) software for medical devices.

How can we help?