Associate Director Combination Products and Medical Devices Biogen
Lori-Ann Woodard is Director, Medical Device in the Compliance Practice at Lachman Consultants. With more than 20 years of experience, Ms. Woodard delivers expertise in the creation and implementation of Quality Management Systems for Medical Devices including Software as a Medical Device (SaMD), and for Combination Products. She is an expert with extensive knowledge and application of the Code of Federal Regulations and International Standards in the Medical Device, Combination Product, and Pharmaceutical industries. This includes applied knowledge of current FDA guidelines for Mobile Medical Applications and FDA Software Precertification Planning. Ms. Woodard has hands-on experience in: Class I, II and III medical devices (including implants); biotech products as pharmaceuticals and as medical devices; IVDs; transdermal patches; respiratory products; polymer-based products; and prefilled syringes.
For nearly four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology
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