Andrea Dwyer Steiner
Expert Regulatory Affairs Consultant | 20+ Yrs PMA, IDE, 510(k), EU MDR | Global Strategy & Approvals
An accomplished Regulatory Affairs professional with over 21 years of distinguished experience in navigating medical device regulations, Andrea Dwyer Steiner excels in authoring submissions and developing regulatory strategies.
About
An accomplished Regulatory Affairs professional with over 21 years of distinguished experience in navigating medical device regulations, Andrea Dwyer Steiner excels in authoring submissions and developing regulatory strategies.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** MedLogics International, LLC
- **Years of experience:** 21
- **510(k)s submitted (self-reported):** 50
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, APAC
- **Client types:** sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** With 21 years of experience and a Master's degree in Regulatory Affairs, this consultant specializes in navigating complex medical device regulations, authoring critical submissions, and developing strategic regulatory plans. Their expertise spans PMA, IDE, 510(k), and EU MDR files, alongside comprehensive CMC supplements. They possess a proven ability to lead and mentor regulatory teams, driving success and fostering a culture of regulatory excellence for innovative medical products. Notably, they have a strong track record of successfully authoring and submitting numerous PMAs, IDEs, 510(k)s, and EU MDR files, leading to timely approvals for diverse medical devices. Their technical competencies include proficiency in regulatory submissions, CMC supplements, and FDA pre-submission meetings. This consultant's unique combination of FDA experience, device expertise, and regulatory depth makes them particularly valuable for medtech companies.
- **Unique value:** This consultant stands out for their unique combination of FDA experience, device expertise, and technical skills, particularly in navigating complex EU MDR regulations and developing strategic regulatory plans. Their ability to lead and mentor regulatory teams, drive success, and foster a culture of regulatory excellence makes them a valuable asset for medtech companies seeking to navigate the complex regulatory landscape.
- **Ideal projects:** The perfect medtech client/project for this consultant involves companies developing Class II and III medical devices, such as cardiovascular, IVD, and SaMD products. They excel in projects requiring complex regulatory strategies, submissions, and international expansion, particularly in the US, EU, and APAC markets. This consultant is best suited for companies seeking expertise in 510(k), De Novo, and PMA submissions, and who value their ability to lead cross-functional teams and manage regulatory documentation. Their ideal engagement point is early in the development process, where they can provide strategic guidance and regulatory planning to ensure timely market access and robust compliance.
- **Last analyzed:** Sat Dec 20 2025 01:50:54 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, international
- **Device classes:** class-ii, class-iii
- **Specialties:** cardiovascular, orthopedic, ivd, software-samd
- **Device panels:** cardiovascular, orthopedic, gastro_urology, obgyn, ivd
- **Regulatory pathways:** 510k, pma, ide, q_sub, post_market
---
- **Type:** independent
- **Company:** MedLogics International, LLC
- **Years of experience:** 21
- **510(k)s submitted (self-reported):** 50
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, APAC
- **Client types:** sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** With 21 years of experience and a Master's degree in Regulatory Affairs, this consultant specializes in navigating complex medical device regulations, authoring critical submissions, and developing strategic regulatory plans. Their expertise spans PMA, IDE, 510(k), and EU MDR files, alongside comprehensive CMC supplements. They possess a proven ability to lead and mentor regulatory teams, driving success and fostering a culture of regulatory excellence for innovative medical products. Notably, they have a strong track record of successfully authoring and submitting numerous PMAs, IDEs, 510(k)s, and EU MDR files, leading to timely approvals for diverse medical devices. Their technical competencies include proficiency in regulatory submissions, CMC supplements, and FDA pre-submission meetings. This consultant's unique combination of FDA experience, device expertise, and regulatory depth makes them particularly valuable for medtech companies.
- **Unique value:** This consultant stands out for their unique combination of FDA experience, device expertise, and technical skills, particularly in navigating complex EU MDR regulations and developing strategic regulatory plans. Their ability to lead and mentor regulatory teams, drive success, and foster a culture of regulatory excellence makes them a valuable asset for medtech companies seeking to navigate the complex regulatory landscape.
- **Ideal projects:** The perfect medtech client/project for this consultant involves companies developing Class II and III medical devices, such as cardiovascular, IVD, and SaMD products. They excel in projects requiring complex regulatory strategies, submissions, and international expansion, particularly in the US, EU, and APAC markets. This consultant is best suited for companies seeking expertise in 510(k), De Novo, and PMA submissions, and who value their ability to lead cross-functional teams and manage regulatory documentation. Their ideal engagement point is early in the development process, where they can provide strategic guidance and regulatory planning to ensure timely market access and robust compliance.
- **Last analyzed:** Sat Dec 20 2025 01:50:54 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, international
- **Device classes:** class-ii, class-iii
- **Specialties:** cardiovascular, orthopedic, ivd, software-samd
- **Device panels:** cardiovascular, orthopedic, gastro_urology, obgyn, ivd
- **Regulatory pathways:** 510k, pma, ide, q_sub, post_market
---
Key Highlights
- With 21 years of experience and a Master's degree in Regulatory Affairs, this consultant specializes in navigating complex medical device regulations, authoring critical submissions, and developing strategic regulatory plans. Their expertise spans PMA, IDE, 510(k), and EU MDR files, alongside comprehensive CMC supplements. They possess a proven ability to lead and mentor regulatory teams, driving success and fostering a culture of regulatory excellence for innovative medical products. Notably, t
- This consultant stands out for their unique combination of FDA experience, device expertise, and technical skills, particularly in navigating complex EU MDR regulations and developing strategic regulatory plans. Their ability to lead and mentor regulatory teams, drive success, and foster a culture of regulatory excellence makes them a valuable asset for medtech companies seeking to navigate the complex regulatory landscape.
Certifications & Trust Signals
- 21 years experience
- 50 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The perfect medtech client/project for this consultant involves companies developing Class II and III medical devices, such as cardiovascular, IVD, and SaMD products. They excel in projects requiring complex regulatory strategies, submissions, and international expansion, particularly in the US, EU, and APAC markets. This consultant is best suited for companies seeking expertise in 510(k), De Novo
HQ:
United States
Languages:
English
Status:
claimed
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), PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
21
Num510k Submitted:
50
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, orthopedic, gastro_urology, obgyn, ivd
Technology Types:
samd, ivd_test, implantable
Accepting New Clients:
No
