BIOGRAPHY

Denise Holliday

Sr. QA/RA Consultant, Schuler Medical Device, Lewisville, TX, USA

With over 20 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Mrs. Holliday provides quality, regulatory, and technical expertise to meet individual client needs.

Mrs. Holliday agrees with the FDA’s “least burdensome approach” and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.

Denise Holliday holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine, and is currently working towards a M.S. in Regulatory Science from Johns Hopkins University.

Additionally, Mrs. Holliday holds several certifications including Regulatory Affairs Certification (RAC) - DEVICES through the Regulatory Affairs Professional Society (RAPS), ASQ certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA), as well as BSI ISO 13485:2016 Lead Auditor certification.

A contributing author and technical reviewer to ASQ’s monthly publication Quality Progress magazine, Mrs. Holliday remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Mrs. Holliday has provided training, workshops, and presentations to small and large audiences alike on topics ranging from QSR, ISO 13485, auditing, and design control to risk management and regulatory readiness and preparation.

Mrs. Holliday also serves as adjunct professor at the University of North Texas within the Biomedical Engineering Department.










ABSTRACT

ISO 9001 to ISO 13485

ISO 9001 defines the requirements for a quality management system (QMS) that can be applied to all industries.ISO 13485 defines the requirements for a QMS that is specific for the medical device industry. The standard aligns with the high-level requirements of ISO 9001, but includes additional requirements, restrictions, and considerations as it relates to the heavily regulated industry.

Are you a manufacturer or supplier of a component used in a medical device and are looking to add ISO 13485 or "upgrade" your current ISO 9001 certification? Are your key customers looking for a vendor that has the tighter controls required for the medical device industry?

Maybe you're a new medical device company looking to set up your QMS and want additional guidance for how to comply with medical device requirements?In this presentation will review the similarities and differences between the two standards and highlight the key considerations when adding in additional requirements.

We'll cover the requirements for document and record control, management responsibility, requirements for equipment, infrastructure and personnel, purchasing and supplier requirements, and the requirements needed for feedback and improvement - specifically complaints, corrective and preventive action (CAPA), handling of nonconformance, and monitoring product performance.

We'll also touch on how to initiate a gap assessment to determine the specific needs for your QMS. We'll review case studies and industry best practices on how many of the requirements are met. We'll finish by summarizing the regulatory requirements of a medical device company, specifically requirements by the US FDA, so that you can fully understand the needs of your customer and the importance of compliance. We'll also provide tips and tricks for management buy-in that may be needed for a QMS revision, as well as discuss the increasing trend by industries across the globe to comply with both standards.













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