About Ietqan

IETQAN means perfection and it is not just our name; it is the core driver that we treasure and the code we strive up to it. Our logo represents the DNA as symbol of perfect object.

IETQAN is offering testing, validation and technical services to private sector and multinational companies throughout Egypt and the Area.

IETQAN committed to keep customer interests as most valuable objective. Maintaining fairness, credibility and customer confidential information is our service delivery back bone.

Jul
02

IETQAN New Web Site Launched

Dear customers
To improve our service we had released improved Web site. The site has a new feature that allow you to access your reports. This will simplify your ability to share the report with your notified body, certification organization and regulatory authorities.

Each report will be accompanied with a password that that will be used with the report number to give access to the report.

To access the feature, please visit the site and:

  1. Tap "Access Report" section at the main menu
  2. Enter document reference number (Report Number)
  3. Enter password (delivered with the hardcopy of report)
  4. Click OK
  5. Welcome note and detailed instructions will appear. You can save it for later use.


THIS Feature is valid for reports issued as of 01/07/2017.

Should you need any help, please  contact us.

Ietqan Services Detail

Residual EO/ECH Analysis

Any medical device that is sterilized by ethylene oxide (EO) and comes in contact with a patient must undergo residual testing to analyze the EO residual levels. The residues can be harmful to the end user or patient, so it is important that all devices meet the limits set forth in the ISO 10993-7 standard. The limits will vary depending upon the intended use of the device. The study should be reviewed periodically, typically with the sterilization process validation, i.e. annually. . (FOR TEST PROTOCOL DETAILS CONTACT US).

Ethylene Oxide Sterilizer Validation

ETO sterilization validation is the documented procedure for obtaining, recording and interpreting the results required to establish that the sterilization process will consistently yield a product complying with predetermined specifications (ISO 11135:2014). Validation of the ETO sterilization process yields a documented procedure of consistently confirming the inactivation of all living microorganisms, confirmation that the product or device is sterile, and confirmation that the process is repeatable. The process validation is a key factor in any regulator with standard compliance technique. IETQAN can concurrently validate more than one sterilizer at a time. Reports are traceable and verifiable through IETQAN web site. This way you will be able to share the report with regulatory agencies and clients with high credibility level. (FOR VALIDATION PROTOCOL DETAILS CONTACT US)

Clean Room Validation

Clean room validations according to (ISO14644-1:2015) the documented procedure for obtaining, recording and interpreting the results required to establish compliance to ISO 14644 requirement. Validation is done according to a predetermined validation protocol. Periodic validations in accordance with a maintenance and validation program tailored to the individual clean room class. In practice, this usually leads to a validation interval of 12 months of clean rooms with ISO class 6 or higher. For clean rooms with ISO class 5 or lower, the validation interval is usually 6 months. Reports are traceable and verifiable through IETQAN web site. This way you will be able to share the report with regulatory agencies and clients with high credibility level. (FOR VALIDATION PROTOCOL DETAILS CONTACT US).

Packaging Validation

ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark.  ISO 11607 is also an FDA Recognized Consensus Standard.  Fulfilling the requirements within ISO 11607 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use. Test reports are traceable and verifiable through IETQAN web site. This way you will be able to share the report with regulatory agencies and clients with high credibility level. (FOR VALIDATION PROTOCOL DETAILS CONTACT US)

Packaging Accelerated Aging Studies

Packaging Accelerated Aging Studies (ISO/IEC 17025:2005 Accredited Service)

Accelerated Aging - oftentimes referred to as Accelerated Shelf-Life Testing - is commonly used in the medical device industry to accelerate the effects of time on a Sterile Barrier System to establish Shelf Life parameters. The process is based on the relationship of temperature and reaction rate where an increase in temperature increases the reaction rate. Following validation ISO 11607 guidelines and ASTM F1980, accelerated aging data can be generated. Accelerated Aging data is acceptable by regulatory bodies as evidence to generate data quickly, but this data is only accepted until those tests can be correlated to "Real Time" samples. (FOR PROTOCOL DETAILS CONTACT US)

Our Credintials

IETQAN is the first and the only ISO 17025 and ISO 17020 accredited company in the middle east specialized in the medical devices sector. IETQAN maintain a system to provide atmost confidence in the services offered for our customers, regulators and their stakeholders.

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Contact Us

Email: ashahean@ietqan.com
Telephone: +2 0100 566 1300
Adress: 10 El-Ashgar St. - Roxy Cairo - Egypt

For any information......
We will be more than happy to answer