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NAMSA

Wound Care Laboratory Testing Requirements: Your Path to Compliance

About

Date/Time

Date(s) - July 11, 2024
10:00 AM - 11:00 AM CT

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In the ever-evolving landscape of wound care, understanding the necessary testing requirements is crucial. The evaluation of a wound dressing depends on the performance of the materials they’re made from, their microarchitecture, and how they’re constructed. To ensure dressings are effective in clinical wound management they must manage the mechanical and biochemical wound environment, effectively absorb exudate, remain in place for the required treatment period, be easily removed, and be acceptable to both patients and health care professionals.

Join us for an informative webinar delving into the critical laboratory testing requirements for wound healing devices. Our speakers will also thoroughly explore FDA and EU regulatory requirements, discuss effective testing strategies, and offer practical insights for navigating unconventional scenarios and novel devices.

Attendees can expect to walk away with a better understanding of:
  • In vitro testing requirements, including the newly updated EN13726 standard
  • Regulatory expectations, with a focus on regional wound care auditors’ requirements
  • The importance of using appropriate test methods to support rapid product development and streamlined routes to regulatory approval

 

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Speaker

Rachel Gibbs, BSc, PhD

Principal Regulatory Consultant

Rachel Gibbs has 15 years’ experience in the medical device and pharmaceutical industries, and also as a Senior Auditor for a leading European Notified Body. Rachel joined NAMSA in 2021 and has used her knowledge of MDR auditing to advise Clients regarding regulatory and clinical strategies, undertaking Gaps Assessments and writing MDR submission documents.

Rachel started her career at the Medicines and Healthcare Products Regulatory Agency (MHRA) working on drug variation and renewal licensing before moving back into academia to conduct a PhD in Immunology. Thereafter, Rachel moved into the pharmaceutical industry, joining 3M Healthcare, working on the development of metered dose inhalers and nasal sprays for U.S. Food and Drug Administration (FDA) and EMEA drug applications. With the opening of 3M’s Skin and Wound Care Laboratory, she transitioned into the medical device industry and was actively involved in new product development for a range of wound care devices, inclusive of design control, risk management, manufacturing upscaling and process validation. Rachel then moved to BSI in 2015 as a Senior Auditor and Clinical Evaluation Specialist involved in product conformity assessment to the Medical Device Directive (93/42/EEC), and subsequently audited against the Medical Device Regulation ([EU] 2017/475).

Shazia A. Siddiqui, MS, NRCM

Principal Microbiologist

Shazia A. Siddiqui has over 20 years of industry experience, with a focus on medical devices including Wound Care, Cardiovascular, Ophthalmology, and Dental areas. She joined NAMSA in 2010 as a Principal Microbiologist, where she plays a key role in developing and improving processes and testing services. Shazia provides technical support to various teams and R&D customers, as well as assistance with microbiological inquiries. With a Master’s degree in Genetics and a Bachelor’s degree in Microbiology, she is a certified Microbiologist and a subject matter expert in the custom microbiological lab at NAMSA. Shazia is an active member of ASTM and AATCC.