About Us

Our mission is to help companies successfully deliver the highest quality products, especially focused within the medical device realm and general software applications.

Carla has twenty-five years’ experience in implementing global strategies,
balancing business needs with compliance risks.
Cross functional background in quality, regulatory and clinical gives a broad
business perspective. Strategically using background as a critical care nurse
and medical device software developer to facilitate understanding between
medical device & diagnostics manufacturers, engineers, clinical customers
and regulators.
Specialty areas include:
 Global Medical Device Regulations, Quality Systems
 ISO 13485:2016 Certified Auditor,
 US FDA: cGMP, QMSR, Part 11
 ISO 62304 Medical Device Software Lifecycle
 EU Medical Device Regulation (MDR)
 Invitro Diagnostic Regulation (IVDR)
 ISO14971 Risk Management
 Medical Device Software Quality,
 Quality & Production (GxP) Software Validations
 HIPAA Privacy / Security
 IEC 62366 Medical Device Usability

Jim is an accomplished Software Quality Professional with a proven track record of delivering quality products that meet business goals. With extensive experience in designing and executing strategic and tactical quality initiatives, he is well skilled at all aspects of software quality assurance, from test plan development, tool creation, automation and execution to metrics reporting and risk assessment. Jim is a highly regarded hands-on manager, leader and mentor with the expertise to build collaborative environments for success.

Jim has presented at many software quality and software testing conferences, as well as serving as a reviewer for ASQ and IEEE publications.