Mentor Documents and Consulting, LLC

Comprehensive Consulting for medical device and pharmaceutical drug manufacturers, construction projects for clean rooms, laboratories, science and technology institutions, manufacturing facilities and government. Mentor Documents and Consulting provides Consulting Services for Quality Management, Regulatory Compliance. We adjust manufacturing operations to meet FDA Quality System requirements (QSR) per 21 CFR Part 820 and ISO 13485. Internal (Mock) Audits per ISO 19011:2018 Auditing, 510(K) Submissions, GUDID UDI Labeling Compliance, Validation Engineering, Project Management, Technical Writers, CAPA Management, current Good Manufacturing Practice (cGMP). Our Medical Device Manufacturing customers are also Specification Developers, startups, Contract Development Manufacturing Organizations - CDMOs (contract manufacturers), and re-labelers or re-processors. Our experts are vetted and hand-picked industry specific experts that are available at a moment’s notice. Whether you’re developing new products, initiating clinical activities, increasing your manufacturing output, validating your processes, or implementing change to maintain regulatory compliance, we have what you need. The people that shape our organization are some of the best in the industry. They are dedicated to making an impact and are with you every step of the way. We strive to meet the most pressing needs, solve the most complex problems, and go beyond expectations for our clients with unrivaled customer service! Reasonable local rates. Call for a quote.