ISO 13485:2016 Certification to Support Pharmaceutical and Microbiological Device Manufacturers

Akron Rubber Development Laboratory, Inc.’s Chemical Services Department, Pharmaceutical and Microbiological testing laboratories are now certified to ISO 13485:2016 in addition to ISO 17025:2017. ISO 13485 is a quality management standard ensuring “consistency in the quality control and assurance process for medical device manufacturing and service industries”. The challenges faced by medical device manufacturers increase daily and ARDL has implemented certification requirements to help customers meet their regulatory goals.  This certification raises the bar for the departments’ expert medical device testing services for pharmaceutical and microbiological analysis clients.  Testing services can be performed on Class I, Class II & Class III medical devices in accordance with the legal instructions of medical device manufactures.

ARDL’s ISO 13485:2016 Certified Testing Includes:
  • ASTM F1670
  • ASTM F1671
  • ASTM D5712
  • ASTM D6499
  • ASTM D7427
  • ASTM F903
  • ASTM F739
  • ASTM D6978
  • ASTM D8238
  • ASTM F813
  • ASTM F895
  • ISO 16603
  • BS EN 374-3
  • DIN EN 16523-1
  • BS EN 455-3 (Section 5.1)

This testing may be performed on any medical device including standard PPE articles such as medical gloves, hospital gowns, surgical drapes, facemasks etc.  Testing is based on the product batch size and includes setup, conditioning and compatibility steps.  ARDL takes the utmost care with customer products as they go through the process of testing in the laboratory, from project initiation to final reporting.

Customers can rest assured that ARDL has taken all necessary precautions to meet testing requirements and protocols by analyzing risk during test implementation to avoid potential problems.  In accordance with the ISO 13485:2016 certification, ARDL follows a strict management and quality system including order review, document control, supplier qualification, part verification, lot identification and traceability, process control, process and software validations, inspection and testing status.

Further, ARDL’s laboratory maintains calibrated measuring devices, control of systems that do not meet requirements and all other facets of ISO 13485 including handling, storage, packing preservation and delivery.  ARDL’s quality control system maintains quality records and performs internal quality audits, training and competency reviews.  ARDL integrates customer feedback and maintains process-based systems to review client communications and risk assessment as well as planning and the continual improvement of processes and equipment.

To learn more about our wide variety of testing and development capabilities for medical devices, pharmaceutical industry products and more please contact our expert staff HERE

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