Techlogic, Inc. is a certified small business concern. We are a Minnesota Corporation--established in 1980. Our Federal FIIN/CAGE is 0SAT1. Techlogic, Inc. provides quality, regulatory and environmental management consulting, training, and related documentation services to clients in the bio-medical, pharmaceutical, software, services, aerospace/defense, automotive, food, railroad, and manufacturing business sectors.
Techlogic, Inc. has served manufacturing, medical devices, and pharmaceutical industries world-wide since 1980. Techlogic, Inc. has carefully selected a core group of quality, regulatory, environmental, and management consultants who have years of experience dealing with strategic management concerns, including concentration in EU MDD and FDA QSR requirements, quality systems such as GMP, ISO-9001, ISO-14969, ISO-13485, ISO-14001, EU CE Marking, and strategic planning to meet critical regulatory and clinical aspects of your business.
From the initial baseline assessment through the final registration audit, Techlogic, Inc. has been successful in helping small, mid-size, and large corporations meet national and international requirements for quality, environment, and safety. Our expertise assures that guesswork and mystery are not a part of your certification process.
Techlogic, Inc. services include conducting mock FDA and ISO audits. Techlogic, Inc. has set up over 450 quality systems world-wide. With the current emphasis on the ISO family of standards, Techlogic, Inc. has developed a meaningful and "cost effective" program to help your company meet those requirements. Our medical and pharmaceutical team members have the expertise required to perform process and equipment validations, software verification and validation, evaluate manufacturing processes, and make meaningful recommendations for improvements. Techlogic, Inc. experience with national and international regulatory and clinical issues is unsurpassed. Internationally, Techlocic, Inc. provides its unique blend of expertise, statutory ,and regulatory requirements to Brazil, Mexico, Canada, Japan, China, Austrailia, New Zealand, Puerto Rico, and the Dominican Republic.
Techlogic, Inc. expertise assures that your company obtains FDA and EU approval for new products "on time, within scope and within budget." Our staff of professionals has successfully obtained hundreds of 510(k) substantial equivalency determinations in all types of bio-medical products. Our strategic planning and implementation expertise allows your company to set up clinical trials for obtaining FDA approval for 510(k) and PMA's.
Techlogic, Inc. routinely conducts seminars on all aspects of the FDA and EU MDD regulations, HACCP, EU CE Marking, Low Voltage Directive, Electromagnetic Compatibility Directive, EC Machinery Directive, Harmonized Standards, ISO-14001 EMS Compliance, OHSAS, and "design and development" strategies. Our seminars are presented world-wide to a wide range of audiences from corporate executives to production planners.
Techlogic, Inc. was founded by Douglas J. Older in 1980. Doug is a degreed quality professional, a certified aerospace/defense quality systems auditor, registered ISO-9001 lead auditor, registered ISO-14001 auditor, certified ILS manager, and a certified management consultant. Doug's expertise is in the critical areas of ISO-9001, ISO-14001, TQM, HACCP, regulatory compliance, and documentation systems development. Doug has worked with a wide-range of companies in the bio-medical, pharmaceutical, aerospace/defense, software, and automotive industries. Company sizes have ranged from startup to $20 billion. Principal activities have focused on facilitating quality system changes for both individuals and organizations; getting better results through improved product and service quality; and enhancing company performance through teamwork and planning.
The Techlogic, Inc. staff consists of a core group of ISO certified lead auditors, ISO-14001 lead auditors, TQM, and regulatory professionals. Techlogic has provided its services locally (Minnesota), nationally (US), and internationally.