TIMOTHY J. JOINER
Global Quality & Regulatory Affairs Leader | FDA & International Compliance | QMS Expert | Device & Combination Products
Highly accomplished Quality and Regulatory Affairs leader with over 25 years of global experience in the medical device, IVD, and combination product sectors. Proven expertise in developing, implementing, and scaling compliant Quality Management Systems (QMS) aligned with FDA and international standards. Skilled in leading global submissions, regulatory strategy, inspection readiness, and post-market surveillance. Passionate about driving continuous improvement, operational excellence, and accelerating innovation to safeguard patient outcomes and enable sustainable growth.
About
Highly accomplished Quality and Regulatory Affairs leader with over 25 years of global experience in the medical device, IVD, and combination product sectors. Proven expertise in developing, implementing, and scaling compliant Quality Management Systems (QMS) aligned with FDA and international standards. Skilled in leading global submissions, regulatory strategy, inspection readiness, and post-market surveillance. Passionate about driving continuous improvement, operational excellence, and accelerating innovation to safeguard patient outcomes and enable sustainable growth.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Qserve Group, US
- **Years of experience:** 26
- **510(k)s submitted (self-reported):** 7
- **Regions served:** US, EU, APAC, MEA
- **Client types:** startup, sme, large_medtech
- **Location:** United States (AZ)
- **Availability:** available_now
- **Certifications:** Certified Quality Auditor, Six Sigma Yellow Belt
---
### **Cruxi analysis**
- **Strength summary:** With 26 years of distinguished global experience, Timothy J. Joiner offers a rare and powerful combination of deep expertise in both Quality Management Systems and Regulatory Affairs. He excels at guiding medtech companies through the entire product lifecycle, from initial regulatory strategy and Q-Submissions to successful 510(k), De Novo, and PMA filings. His proficiency with complex technologies like SaMD, combination products, and IVDs, coupled with his ability to scale compliant QMS for FDA, EU MDR, and MDSAP standards, makes him an invaluable strategic partner. Companies benefit from his proven ability to not only achieve market access but also to build robust, inspection-ready quality infrastructures that support sustainable growth.
- **Unique value:** Timothy's key differentiator is his ability to seamlessly integrate high-level regulatory strategy with hands-on QMS implementation and operational excellence. He doesn't just help you get your product cleared; he builds the compliant, scalable quality framework your company needs to thrive in a global market. This holistic approach, bridging the gap between regulatory submissions and sustainable quality assurance, is what makes him a standout asset for any ambitious medtech organization.
- **Ideal projects:** The ideal project for Timothy involves a medtech company, from a startup to a large enterprise, developing a complex or novel device such as a cardiovascular implant, IVD, or combination product. He is perfectly suited for companies seeking to establish their first compliant QMS, expand into international markets (EU, APAC), or prepare for critical FDA inspections and audits. Medtech firms navigating challenging regulatory pathways like a De Novo submission, requiring end-to-end 510(k) authoring, or needing strategic support for post-market surveillance and QMS harmonization after an acquisition would find his expertise exceptionally valuable. Engaging him early in the process ensures a solid foundation for both regulatory success and long-term compliance.
- **Last analyzed:** Mon Dec 29 2025 15:55:02 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** qms, international, 510k-traditional, 510k-special, de-novo, pma
- **Device classes:** class-ii, class-iii, class-i
- **Specialties:** software-samd, ivd, other, cardiovascular, ophthalmic, dental, orthopedic, general-hospital
- **Device panels:** ivd, other, cardiovascular, orthopedic, obgyn, dental, general_surgery, radiology
- **Regulatory pathways:** q_sub, post_market, 510k, de_novo, ide
---
- **Type:** independent
- **Company:** Qserve Group, US
- **Years of experience:** 26
- **510(k)s submitted (self-reported):** 7
- **Regions served:** US, EU, APAC, MEA
- **Client types:** startup, sme, large_medtech
- **Location:** United States (AZ)
- **Availability:** available_now
- **Certifications:** Certified Quality Auditor, Six Sigma Yellow Belt
---
### **Cruxi analysis**
- **Strength summary:** With 26 years of distinguished global experience, Timothy J. Joiner offers a rare and powerful combination of deep expertise in both Quality Management Systems and Regulatory Affairs. He excels at guiding medtech companies through the entire product lifecycle, from initial regulatory strategy and Q-Submissions to successful 510(k), De Novo, and PMA filings. His proficiency with complex technologies like SaMD, combination products, and IVDs, coupled with his ability to scale compliant QMS for FDA, EU MDR, and MDSAP standards, makes him an invaluable strategic partner. Companies benefit from his proven ability to not only achieve market access but also to build robust, inspection-ready quality infrastructures that support sustainable growth.
- **Unique value:** Timothy's key differentiator is his ability to seamlessly integrate high-level regulatory strategy with hands-on QMS implementation and operational excellence. He doesn't just help you get your product cleared; he builds the compliant, scalable quality framework your company needs to thrive in a global market. This holistic approach, bridging the gap between regulatory submissions and sustainable quality assurance, is what makes him a standout asset for any ambitious medtech organization.
- **Ideal projects:** The ideal project for Timothy involves a medtech company, from a startup to a large enterprise, developing a complex or novel device such as a cardiovascular implant, IVD, or combination product. He is perfectly suited for companies seeking to establish their first compliant QMS, expand into international markets (EU, APAC), or prepare for critical FDA inspections and audits. Medtech firms navigating challenging regulatory pathways like a De Novo submission, requiring end-to-end 510(k) authoring, or needing strategic support for post-market surveillance and QMS harmonization after an acquisition would find his expertise exceptionally valuable. Engaging him early in the process ensures a solid foundation for both regulatory success and long-term compliance.
- **Last analyzed:** Mon Dec 29 2025 15:55:02 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** qms, international, 510k-traditional, 510k-special, de-novo, pma
- **Device classes:** class-ii, class-iii, class-i
- **Specialties:** software-samd, ivd, other, cardiovascular, ophthalmic, dental, orthopedic, general-hospital
- **Device panels:** ivd, other, cardiovascular, orthopedic, obgyn, dental, general_surgery, radiology
- **Regulatory pathways:** q_sub, post_market, 510k, de_novo, ide
---
Key Highlights
- With 26 years of distinguished global experience, Timothy J. Joiner offers a rare and powerful combination of deep expertise in both Quality Management Systems and Regulatory Affairs. He excels at guiding medtech companies through the entire product lifecycle, from initial regulatory strategy and Q-Submissions to successful 510(k), De Novo, and PMA filings. His proficiency with complex technologies like SaMD, combination products, and IVDs, coupled with his ability to scale compliant QMS for FDA
- Timothy's key differentiator is his ability to seamlessly integrate high-level regulatory strategy with hands-on QMS implementation and operational excellence. He doesn't just help you get your product cleared; he builds the compliant, scalable quality framework your company needs to thrive in a global market. This holistic approach, bridging the gap between regulatory submissions and sustainable quality assurance, is what makes him a standout asset for any ambitious medtech organization.
Certifications & Trust Signals
- 26 years experience
- 7 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project for Timothy involves a medtech company, from a startup to a large enterprise, developing a complex or novel device such as a cardiovascular implant, IVD, or combination product. He is perfectly suited for companies seeking to establish their first compliant QMS, expand into international markets (EU, APAC), or prepare for critical FDA inspections and audits. Medtech firms navigat
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), Special 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
26
Num510k Submitted:
7
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd, other, cardiovascular, orthopedic, obgyn, dental, general_surgery, radiology
Technology Types:
samd, combo_product, ivd_test, mobile_app, implantable
Accepting New Clients:
No
