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June 6, 2001:

Integrity Design & Test Services Announces
Conformity Assessment Body Designation

 LITTLETON, MA— Integrity Design & Test Services, an Entela, Inc. Company, announces its designation as a Conformity Assessment Body (CAB) under the EMC Directive.  Integrity received its designation as a CAB through the National Institute of Standards and Technology.

Integrity is now authorized to provide documentation in support of U.S. manufacturers seeking to demonstrate compliance with European legal, regulatory and administrative requirements covered under the EMC Annex of the MRA (Mutual Recognition Agreement).  Integrity’s CAB designation replaces the need for working with a Notified Body in Europe and establishes Integrity’s qualification to complete test suite review, grant final approval of technical construction files, and provide a statement of compliance directly to the client.  These enhanced services will assure faster project turnaround time, since clients are no longer required to seek additional approval from a European Notified Body if they utilize a Conformity Assessment Body.

“The designation of Integrity as a CAB under the EMC Directive furthers the Entela family’s ever-growing list of accreditations and recognitions,” said Ms. Kim Phillipi, President of Entela, Inc.  “This demonstrates our commitment to provide our customers with a full spectrum of quality services in our testing and product certification divisions.”

May 24, 2001: 

Entela, Inc., Receives Expanded Accreditation
to Conduct FDA

Accredited Persons Third-Party 510(k)
Reviews for Medical Devices

GRAND RAPIDS, MI— Entela, Inc. announces they have been accepted into the U.S. FDA (Food and Drug Association) Accredited Persons Third Party Review Expanded Pilot Program for the review of  FDA 510(k) submissions for Medical Devices.

In an effort to encourage greater use of the Accredited Persons Program, the FDA implemented an expansion pilot in January 2001 that allows Accredited Persons to review many Class II devices that were not previously eligible. The pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents.

Reviews and recommendations from Entela will be accepted by the FDA.  Entela will assess Class II Medical Devices, providing the manufacturers of eligible medical devices an alternative review process that yields more rapid 510(k) decisions.  Examples of Class II Medical Devices eligible in the pilot program include  Electronic Stethoscope, Vascular Clamp, Medical Ultraviolet Air Purifier and Fetal Cardiac Monitor.

Through the accreditation process Entela, Inc. demonstrated the appropriate qualifications and facilities to conduct competent 510(k) reviews.  Entela institutes rigorous and effective controls to prevent any potential conflict of interest that might affect the review process.

“Acceptance to this pilot program only further enhances Entela’s capabilities as an international product certification organization.” commented Ms. Kim Phillipi, President of Entela, Inc.  “Entela strives to offer a complete package of third-party product and system certification services. Our clients want a one-stop-shop, and this acceptance supports our goals to meet all our clients’ needs.”

April 16, 2001:

Entela, Inc. Announces ISO/IEC 17025 Accreditation

GRAND RAPIDS, MI— Entela, Inc. Engineering and Testing Laboratories announces its accreditation to ISO/IEC Guide 17025.  One of the first labs in the world to comply with the new standard, Entela, Inc. received its accreditation from the American Association for Laboratory Accreditation (A2LA). 

ISO/IEC Guide 17025 replaces ISO/IEC Guide 25 and EN 45001.  This International Standard contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate an effective quality system, are technically competent, and are capable of generating technically valid results.   Elements of ISO 9001 and ISO 9002 that are relevant to the scope of testing and calibration services that are covered by a laboratory’s quality system are incorporated in ISO/IEC Guide 17025.  Additionally, the third edition of QS-9000 requires Automotive suppliers to use ISO/IEC 17025 accredited facilities.
Through the accreditation process, Entela, Inc. demonstrated the appropriate qualifications to produce technically valid test data and results.  Entela, Inc., an OSHA Nationally Recognized Testing Laboratory (NRTL), institutes rigorous and effective quality controls in order to meet compliance with ISO/IEC Guide 17025 requirements.  Entela’s Grand Rapids, Detroit, and Boston (under the name Integrity Design and Test Services) labs are all accredited to the new standard.

“Entela is proud to be a leader in ISO/IEC Guide 17025 accreditation,” said Ms. Kim Phillipi, President of Entela, Inc.  “This demonstrates our commitment to having a proven quality system in place which will insure our customers of receiving the most reliable and accurate test data possible.”

For more information contact:  Linda Hall, Marketing Specialist, 1-800-888-3787 or 616-247-0515, ext. 5604

Entela, Inc., is an international company, founded as a Michigan corporation in 1974.  Today, Entela is one of the fastest growing privately held firms in Michigan.  Entela, Inc., provides Full Product, Systems and Material/Component Testing and Failure Analysis, Global Conformity Assessment to International, North American and European Standards, Management System Registration (ISO 9000, QS-9000, TE Supplement, ISO/TS 16949, ISO 14000, TL 9000 and VDA 6.1), Engineering Services, Accelerated Testing and Failure Mode Verification Testing (FMVT^®).  In addition to its Grand Rapids, Mich. headquarters, Entela has facilities in Detroit, MI.; Boston, MA.; Toronto, Ontario, Canada; Hong Kong and Taipei, Taiwan.