Hunter Strategies Partner Jim Becker has overseen the development of safety critical products in two widely seperated industries.  In the first case,  at PHT, the software was used to gather the data generated in pharmaceutical trials and was regulated by the Federal Drug Administration (FDA).  In the second case at Wingspeed, the software and hardware was installed in commercial aircraft to provide data communications and processing capability and was regulated by the Federal Aviation Administration (FAA).  The requirements of the regulatory agencies force the product development process to be significantly different then that for normal commercial software.  

At Wingspeed,  Jim lead the certification process working closely with the FAA’s Systems and Software Designated Engineering Representative, insuring all the objectives of DO178, DO160 and DO254 were met.  Jim wrote the majority of the certification documents and oversaw many of the tests that resulted in approval of Wingspeed’s communication and computing systems.   At PHT Jim worked with the development team to insure the software met the requirement of CFR 21 Part 11 and participated in the audits by pharmaceutical customers.

Hunter Strategies can assist you with setting up, managing and operating programs requiring certified software and hardware.