Medical Device Packaging Validation & Testing for Regulatory Compliance

Complimentary Webinar: Medical Device Packaging: Validation & Testing for Regulatory Compliance

Medical device packaging testing encompasses a range of tests designed to assess the suitability and sterility of packaging materials for use with a given device, IVD and / or their accessories.

For any given medical procedure, the likelihood of survival of microorganisms is verified by their number & resistance and by the conditions in which the organisms exist during treatment. As a result, there can never be an assurance on the sterility of any one item in a batch of items subjected to sterilization processing.

Join our complimentary webinar, as our expert practitioner explains the benefits and challenges of how this can be addressed with a robust testing & validation process, and how our full range solutions on medical device packaging testing can support your needs from design to aftermarket and mitigate risks. Further understand key aspects and insights, covering an overall landscape of medical device packaging and its importance to conform with regulatory mandates.

Details:

  • Date: Tuesday, 25th June 2024
  • Time: 2.30 pm IST
  • Speaker: Mr. Pavankumar Tailor

Summary & agenda:

  • Severity of packaging failures
  • Packaging testing - Overview & parameters
  • Regulatory requirements

Who should attend?

  • Manufacturers and operators of medical devices
  • Product managers
  • Risk managers
  • Compliance officers
  • Regulatory specialists

Meet our expert

Mr. Pavankumar Tailor

 

Mr. Pavankumar Tailor

Senior Research Associate - Healthcare and Medical Devices TÜV SÜD

 

Mr. Pavankumar Tailor serves as a senior research associate for packaging and mechanical testing at the Healthcare and Medical Devices division of TÜV SÜD South Asia. His extensive experience in the areas of QA / QC, regulatory affairs and research & development for multiple medical device organizations and manufacturers, further enables him to interact with global clients and conduct packaging and engineering tests associated with medical devices.

Pavankumar is a qualified mechanical engineer, with a CQI-IRCA certified ISO 13485 Lead Auditor Certification. His core expertise lies in the research & development of medical devices, from its verification & validation stage to the end production evaluation and regulations associated with the same.

At TÜV SÜD, he oversees engineering test evaluation and validation procedures at the Biological Safety, Reusable Device & Lot Release Testing (BRL) lab.

JOIN US FOR THIS WEBINAR

Learn an overall landscape of medical device packaging and its importance to conform with regulatory mandates.

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