Incorporated--Adding Quality Since 1965
Inc. is a "world-class" ISO-9001, ISO-14969, AS-9100, ISO-14001,
ISO-13485, TQM, HACCP, FDA 510(k), MDD, CE Marking, LVD, EMC, EC Machinery
Directive, and Documentation Systems consulting and training company. We provide
personnel and services to augment your quality assurance/quality control,
environmental control, and regulatory affairs groups. Techlogic, Inc. has
successfully led over 350 companies through the ISO certification process; all
companies passed the registration audit on their first try!.
Inc. is dedicated to providing exceptional, "world-class"
quality assurance/quality control consulting, management consulting, regulatory
submissions, and documentation preparation services. We strive to deliver our
products and services within a framework of professional competence, ethical
conduct, and practical value.
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, and manufacturing business sectors.
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 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.
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
Inc. services include conducting mock FDA and ISO audits. Techlogic, Inc.
has set up over 350 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
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.
Inc. routinely conducts seminars on all aspects of the FDA and EU MDD
regulations, HACCP, CE Marking, Low Voltage Directive, Electromagnetic
Compatibility Directive, EC Machinery Directive, Harmonized Standards, ISO-14001
EMS Compliance, and "design and development" strategies. Our
seminars are presented world-wide to a wide range of audiences from corporate
executives to production planners.
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.
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
(Canada, France, Germany, Japan, Puerto Rico, Mexico, and Poland).
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5151 Edina Industrial
Blvd., Ste. 299, Edina, MN 55439