Company History

OMEDtech was founded in 2002 with the primary mission of consulting with companies to successfully meet their quality and regulatory challenges. Over the years, OMEDtech has stayed current on changing regulations and requirements such as: identification of regulatory pathways, regulatory submissions, quality management systems, internal and supplier auditing, and new regulatory and quality requirements.

Management Team

David Makanani

Principal, CEO

30+ years of medical device experience focused on development, regulatory and commercialization of medical devices. David worked for FDA prior to his industry experience specializing in medical device requirements. David is a graduate of the University of Oklahoma.

Stephen Ford

Principal, President

30+ years of medical device experience focused on development and commercialization of medical devices. Mr. Ford is a graduate of Texas Tech University and the University of Texas at Arlington.

Consulting Experience

OMEDtech plays a key role in facilitating the commercialization of diverse medical devices ranging from Class III active implantables to Class I products with regulatory submissions. Our company has experience consulting on product development, design control, clinical trials, regulatory affairs, develop and maintain quality management systems, PMAs, 510ks, and CE technical files. We are always adapting to current regulations and offering new services in relation to the ever changing regulatory landscape.

How We Can Help

OMEDtech works with you to meet the challenges of new product approvals, identifying and correcting regulatory deficiencies, improving operational systems and filling the gap when resources are limited and schedules are unrelenting. A few areas of expertise include:

  • Quality Management System Regulation (QMSR) Transition
  • IDE (Investigational Device Exemption) and HDE (Humanitarian Device Exemption) Submissions- PMA (PreMarket Approval) Applications and 510K Notifications
  • Quality System Development and Implementation
  • Manufacturing Process Development and Management
  • Quality System Reviews, GAP analysis, Audits
  • ISO 13485:2016 Certification Assistance
  • Engineering Support for Pre-Clinical Testing
  • Interfacing with International regulatory bodies for CE Marking in the EU
  • Warning letter and Form 483 analysis and response

Our goal is to provide a cost-effective solution from concept to market for companies with limited resources. OMEDtech is available to help either in a small or large way, and will not add to your long term overhead expense.