About Us
TRR is a versatile RA/QA consulting firm in the Quality Auditing, Quality Management Systems, Regulatory Affairs, Global Regulatory Submissions (including FDA and European CE Mark, and other geographies) and Compliance (Audit Preparation, Audit Training, Audit Defense, Audit Support, Internal Auditing) Space specializing in the medical device space. Dallas has a passion for all-things regulatory, auditing, and quality in the medical devices space and brings his certifications and graduate degrees to provide only value-added RA/QA support.
How We Got Started
After working in a number of large medical device manufacturers, our founder felt he could transfer that experience to provide clients a better regulatory and quality experience at a better value. To that end, TRR was founded on the principles of providing LEAN regulatory and quality and auditing support to the industry at a competitive rate in order to get client products through regulatory marketing clearance quicker and get ISO certification quicker (ISO 9001 and ISO 13485).
Our Customers
Medical Device Manufacturers of all sizes and all stages of the product life cycle, Start-up Med Device Companies, Clinician Inventors, Venture Companies, Large companies. TRR is available to travel domestically and abroad as clients may need.
Clients We Have Worked With:
Zimmer
Biomet
Terumo
Bolton Medical
CP Medical
Vycor Medical
Namsa
Bausch + Lomb
Valeant
We offer Value-Added Medical Device Quality Auditing and Regulatory Affairs
Do you have a global regulatory submissions plan that includes FDA (510k or Pre-Sub or Pre-IDE), European Union CE Mark, Health Canada Licenses, Asia submissions, Latin America Submissions? We can provide a regulatory assessment for your company.
Quality Auditing, Audit Prep, and Audit Support and Remediation
We conduct internal quality systems audits to find any gaps and ensure your quality system is robust and ensuring continuous improvement. We have assisted clients with their ISO 13458:2016 Transitions, MDSAP Transition, and their FDA remediation after inspections. We also train for audit preparation and proven tactics to pass your audit with flying colors (ISO, MDSAP, Notified Body, FDA, Brazil-ANVISA, Australia-TGA, Health Canada, CE Mark Audits, Japan-PMDA / MHLW, Etc.) If you need on site support to defend your company during your audit, rest assured that we will be there for you. We are also experienced in post audit remediations (MDSAP AOs, Registrars, FDA 483 and Warning Letters, Notified Bodies, ANVISA,,etc.)
Multi-Lingual Services
Fluent in Spanish and Portuguese.
Availability:
Working for your needs.
We are willing to work with you on a project by project basis.
Offering part time and on demand support as well.
Ongoing regulatory, quality, and auditing support or periodically as needed.
Available to travel on site as needed.
Also available for virtual / remote work to reduce costs to your company.
Regulatory Affairs:
Regulatory Roadmap to Market
FDA Audit / Inspection Defense (21 CFR 820 QSRs)
FDA Audit / Inspection Remediation (21 CFR 820 QSRs)
Mock FDA Audit / Inspection (21 CFR 820 QSRs)
FDA 510(k) Submission / Pre-FDA Review
FDA 483 Remediation
Warning Letter Remediation
EU CE Marking (MDD 93/42/EEC)
EU MDR Transition (MDR 2017/745)
EU Technical File / Design Dossiers
EU Notified Body Support
Mock EU Audit (TF / DD)
ISO 13485:2016 Transition
1st Time QMS
Internal Audits
Supplier Audits
Supplier Qualification
ISO 9001
Notified Body Support
External Audit
Regulatory and Quality Training
International Submissions (EU, LATAM, Canada, Mexico, Brazil, etc.)
FDA US Agent
Clinical Evaluation CER Creation & Support per MEDDEV 2.7/1 Rev 4
EU Medical Device Regulation (MDD to MDR) Gap Analysis
EU MDR Implementation