Your Champion for Product Success

LaVonne Waldon

LaVonne Waldon Paladin Medical Device Regulatory ServicesLaVonne Waldon
Client Services Manager
Office Manager

LaVonne Waldon is Client Services Manager at Paladin Medical®, Inc.

LaVonne’s first responsibility is to ensure the clients have what they need to facilitate company services. She provides a wide range of skills to ensure smooth office management and communication with the clients. She facilitates communication between the President and other consulting staff concerning client requirements.

Ms. Waldon is responsible for accounts receivable and all client invoices. She is also the office specialist in various technical and accounting software databases. She manages the client document portal and interfaces with website and IT services to maintain office functions.

Ms. Waldon oversees production of the submission publication phase for FDA applications, converting and compiling the variety of document types to the format accepted by FDA. She ensures the applications are done and out the door on time.

LaVonne manages the office “library”, which includes template procedures for quality systems and technical training articles on medical device issues ranging from biomaterials to software validation. The Paladin Medical®, Inc. training and education database has proven time and time again to provide the information to clients as its needed in their corporate development.

To keep abreast of the everchanging medical device industry; Ms. Waldon constantly strives to improve Paladin quality system template by reviewing both US and International regulations including the impact of ISO 13485:2016 and how the standard may require changes to the medical device manufacturers’ quality management systems (QMS) and FDA’s Proposed Quality Management System Regulation (QMSR).

The ISO 13485:2016 is a global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and post-market surveillance requirements. Beginning February 28, 2019, the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”

“Paladin Medical® continues to recommend that small startups initiate their quality systems based on 21 CFR 820 and ISO 13485:2016. Our templates assist the clients to establish, implement and maintain a compliant quality system.

For more details about our many services and customized training, please contact us. Please connect with us on LinkedIn

Paladin Medical Device Regulatory Services AIMBE logo Paladin Medical Device Regulatory Services institute for Decarbonization and Energy Advancement Paladin Medical Device Regulatory Services Department of regulatory affairs Paladin Medical Device Regulatory Society for Bio-Materials Paladin Medical Device Regulatory Services Department of regulatory affairs