Techlogic
Techlogic, Inc. is a professional consulting and training company specializing in quality, regulatory, and environmental management systems. Established in 1980 and based in Minnesota, it provides services to a wide range of industries including bio-medical, pharmaceutical, aerospace, defense, automotive, and more. The company has successfully led over 450 companies through ISO certification processes and offers a comprehensive suite of services including implementation, training, and strategic planning for various standards such as ISO-9001, ISO-13485, ISO-14001, FDA QSR, and industry-specific standards like AS-9100. Their mission is to deliver world-class quality assurance, management consulting, and regulatory services with professionalism, ethics, and practical value.
Industries
Nr. of Employees
small (1-50)
Techlogic
Eden Prairie, Minnesota, United States, North America
Services
Consulting services covering QMS implementation, regulatory strategy, documentation systems, and audit support for biomedical, pharmaceutical, aerospace, automotive, food, railroad, and general manufacturing sectors.
Implementation and training services for ISO 9001, ISO 13485, ISO 14001, AS9100 including steering team setup, documentation training, internal auditor training, and pre-assessment audits.
Services to support FDA QSR compliance, DMR/DHF/DHR preparation, 510(k)/PMA submission preparation, and clinical/regulatory affairs consulting.
Training and consulting for process validation (IQ/OQ/PQ), equipment qualification, and software verification and validation.
Consulting and training in ISO 31000-aligned risk management, P/DFMEA, hazard analysis, and life-cycle assessment.
Advisory services and training on sterilization practices, bioburden control, and environmental monitoring for regulated manufacturing environments.
Consulting services covering QMS implementation, regulatory strategy, documentation systems, and audit support for biomedical, pharmaceutical, aerospace, automotive, food, railroad, and general manufacturing sectors.
Implementation and training services for ISO 9001, ISO 13485, ISO 14001, AS9100 including steering team setup, documentation training, internal auditor training, and pre-assessment audits.
Services to support FDA QSR compliance, DMR/DHF/DHR preparation, 510(k)/PMA submission preparation, and clinical/regulatory affairs consulting.
Training and consulting for process validation (IQ/OQ/PQ), equipment qualification, and software verification and validation.
Consulting and training in ISO 31000-aligned risk management, P/DFMEA, hazard analysis, and life-cycle assessment.
Advisory services and training on sterilization practices, bioburden control, and environmental monitoring for regulated manufacturing environments.
Expertise Areas
- Quality management systems implementation
- Regulatory submissions and compliance (FDA and EU)
- Medical device regulatory strategy and technical dossiers
- Aerospace quality systems (AS9100)
Key Technologies
- IQ/OQ/PQ process validation
- Software verification and validation
- Failure modes and effects analysis (FMEA)
- Life-cycle assessment (LCA)
News & Updates
Please call for upcoming class schedule or to set your own date.
Please call for upcoming class schedule or to set your own date.