Consulting Services

Consulting services are available for a wide range of quality system needs for both medical device and pharmaceutical manufacturers. This includes establishing, maintaining or remediation of entire quality systems or specific clauses. Our staff has decades of industry experience with the following from both an industry and Notified Body perspective:

CFR 211

CFR 820

ISO 13485:2016

ISO 9001:2015

Technical consulting is available for all modes of sterilization as well as supporting microbiology processes, including bioburden, environmental monitoring and other assays. We can help with process development, optimization and remediation activities as well as selection and approval of vendors and ongoing supplier quality activities.

AAMI/ISO 11135

AAMI/ISO 11137

AAMI/ISO 11737

AAMI/ISO 17665

ISO 14644