Our successful approach and knowledgeable staff have led to invitations from industry and regulatory workgroups to help shape future practices and standards for the Medical Device Industry.
Intertech has contributed significant time and resources reviewing and contributing to ANSI/AAMI/IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes and its predecessor AAMI/ANSI SW:68. Intertech also contributed resources to the development of AAMI TIR32:Medical Device Software Risk Management. Currently, Intertech is working with another AAMI workgroup on a Technical Information Report (TIR) on the Validation of Software for Regulated Processes.
Our principals also lead industry training programs that shape the current practices of both early stage companies and industry giants. Intertech is also represented on the editorial advisory boards of MD&DI magazine and Device & Diagnostics Letter.