Tammy Lavery
Seasoned Global Quality & Regulatory Executive | Medical Devices | FDA Submissions, QMS & EU MDR Expert
A seasoned Global Quality and Regulatory Compliance Executive with over two decades of leadership in the medical device industry. Tammy Lavery possesses deep expertise in securing FDA approvals, developing and implementing global regulatory strategies, and managing robust Quality Management Systems (ISO 13485, MDSAP). Her experience spans new product development, risk management (ISO 14971), clinical study compliance, and post-market surveillance. She excels in building strong relationships with regulatory authorities and leading cross-functional teams to achieve compliance and commercial success across US, EU, and Canadian markets. Her background includes roles from hands-on consulting to VP of RA/QA, demonstrating a versatile ability to support companies of all sizes.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
30
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, radiology, general_surgery, dental, anesthesiology, wearable_digital
Technology Types:
samd, mobile_app, cloud_platform, wearable_patch, implantable
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
