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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 30
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA
- **Client types:** startup, sme, large_medtech
- **Location:** United States (UT)
- **Availability:** available_now
- **Certifications:** Regulatory Affairs Certification, Preparing the CMC Section for NDAs/INDs/CTDs, Clinical Research Assistant 10 Week On-Boarding, Collaborative Institutional Training Initiative (Citi Program)
### **Cruxi analysis**
- **Strength summary:** Tammy Lavery offers medtech companies a powerful combination of executive-level strategic vision and hands-on regulatory execution, backed by 30 years of industry leadership. Her deep expertise spans the most challenging regulatory pathways, including 510(k), De Novo, and PMA submissions, for a wide range of complex devices such as cardiovascular, SaMD, and implantables (Class I-III). What truly distinguishes Tammy is her versatile experience, having served as a VP of RA/QA and a direct consultant, enabling her to effectively guide both startups and large corporations through the entire product lifecycle. She is a proven leader in developing global regulatory strategies for US, EU, and Canadian markets, managing robust ISO 13485/MDSAP compliant QMS, and securing critical market approvals, making her an invaluable asset for achieving commercial success.
- **Unique value:** Tammy Lavery's unique value lies in her rare ability to blend C-suite level global regulatory strategy with the hands-on, meticulous execution required for complex submissions and QMS implementation. This versatility, honed over 30 years in roles from consultant to VP, allows her to seamlessly guide companies of any size—from startups to large corporations—through the entire product lifecycle across US, EU, and Canadian markets. She is a comprehensive RA/QA partner who can build the foundation for compliance and then lead the charge to commercial success.
- **Ideal projects:** The ideal client for Tammy Lavery is a medtech company, from a lean startup to an established enterprise, developing complex Class II or Class III devices, particularly in the cardiovascular, radiology, or SaMD sectors. She is perfectly suited for companies needing end-to-end regulatory leadership, from initial pathway assessment and Q-Sub strategy to the full authoring of a 510(k), De Novo, or PMA submission. Organizations seeking to establish a robust, compliant QMS (ISO 13485/MDSAP) or navigate the complexities of international expansion into the EU and Canada will find her strategic guidance invaluable. Companies facing their first major FDA submission, undergoing an EU MDR transition, or requiring senior expertise to manage interactions with regulatory bodies represent a perfect match for her skillset.
- **Confidence score:** 90/100
- **Last analyzed:** Mon Dec 22 2025 01:38:11 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** cardiovascular, radiology, dental, ophthalmic, general-hospital, anesthesiology, software-samd
- **Device panels:** cardiovascular, radiology, general_surgery, dental, anesthesiology, wearable_digital
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, post_market
- **Type:** independent
- **Years of experience:** 30
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA
- **Client types:** startup, sme, large_medtech
- **Location:** United States (UT)
- **Availability:** available_now
- **Certifications:** Regulatory Affairs Certification, Preparing the CMC Section for NDAs/INDs/CTDs, Clinical Research Assistant 10 Week On-Boarding, Collaborative Institutional Training Initiative (Citi Program)
### **Cruxi analysis**
- **Strength summary:** Tammy Lavery offers medtech companies a powerful combination of executive-level strategic vision and hands-on regulatory execution, backed by 30 years of industry leadership. Her deep expertise spans the most challenging regulatory pathways, including 510(k), De Novo, and PMA submissions, for a wide range of complex devices such as cardiovascular, SaMD, and implantables (Class I-III). What truly distinguishes Tammy is her versatile experience, having served as a VP of RA/QA and a direct consultant, enabling her to effectively guide both startups and large corporations through the entire product lifecycle. She is a proven leader in developing global regulatory strategies for US, EU, and Canadian markets, managing robust ISO 13485/MDSAP compliant QMS, and securing critical market approvals, making her an invaluable asset for achieving commercial success.
- **Unique value:** Tammy Lavery's unique value lies in her rare ability to blend C-suite level global regulatory strategy with the hands-on, meticulous execution required for complex submissions and QMS implementation. This versatility, honed over 30 years in roles from consultant to VP, allows her to seamlessly guide companies of any size—from startups to large corporations—through the entire product lifecycle across US, EU, and Canadian markets. She is a comprehensive RA/QA partner who can build the foundation for compliance and then lead the charge to commercial success.
- **Ideal projects:** The ideal client for Tammy Lavery is a medtech company, from a lean startup to an established enterprise, developing complex Class II or Class III devices, particularly in the cardiovascular, radiology, or SaMD sectors. She is perfectly suited for companies needing end-to-end regulatory leadership, from initial pathway assessment and Q-Sub strategy to the full authoring of a 510(k), De Novo, or PMA submission. Organizations seeking to establish a robust, compliant QMS (ISO 13485/MDSAP) or navigate the complexities of international expansion into the EU and Canada will find her strategic guidance invaluable. Companies facing their first major FDA submission, undergoing an EU MDR transition, or requiring senior expertise to manage interactions with regulatory bodies represent a perfect match for her skillset.
- **Confidence score:** 90/100
- **Last analyzed:** Mon Dec 22 2025 01:38:11 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** cardiovascular, radiology, dental, ophthalmic, general-hospital, anesthesiology, software-samd
- **Device panels:** cardiovascular, radiology, general_surgery, dental, anesthesiology, wearable_digital
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, post_market
Key Highlights
- Tammy Lavery offers medtech companies a powerful combination of executive-level strategic vision and hands-on regulatory execution, backed by 30 years of industry leadership. Her deep expertise spans the most challenging regulatory pathways, including 510(k), De Novo, and PMA submissions, for a wide range of complex devices such as cardiovascular, SaMD, and implantables (Class I-III). What truly distinguishes Tammy is her versatile experience, having served as a VP of RA/QA and a direct consulta
- Tammy Lavery's unique value lies in her rare ability to blend C-suite level global regulatory strategy with the hands-on, meticulous execution required for complex submissions and QMS implementation. This versatility, honed over 30 years in roles from consultant to VP, allows her to seamlessly guide companies of any size—from startups to large corporations—through the entire product lifecycle across US, EU, and Canadian markets. She is a comprehensive RA/QA partner who can build the foundation f
Certifications & Trust Signals
- 30 years experience
Buyer Snapshot
Best for
- The ideal client for Tammy Lavery is a medtech company, from a lean startup to an established enterprise, developing complex Class II or Class III devices, particularly in the cardiovascular, radiology, or SaMD sectors. She is perfectly suited for companies needing end-to-end regulatory leadership, from initial pathway assessment and Q-Sub strategy to the full authoring of a 510(k), De Novo, or PM
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA, 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
