Mentor Documents and Consulting provides Consulting Services for Quality Management, Regulatory Compliance, 510(K) Submissions, GUDID UDI Labeling Compliance, Validation Engineering, Project Management, Technical Writers, CAPA Management, current Good Manufacturing Practice (cGMP). Our Medical Device Manufacturing customers are also Specification Developers, start-ups, Contract Development Manufacturing Organizations – CDMOs (contract manufacturers), and re-labelers/re-processors. We can help with… Continue reading Mentor Documents and Consulting
Location: Austin
Freeman, Craft, McGregor: Validation Department
FCM’s Validation Department provides medical device/pharmaceutical companies with customized risk-based validation of quality-affecting software, automated equipment, and processes. This includes preparation for FDA audits, establishment of new product lines, and migration to new quality management systems.
ATX Medical Innovations
We have created an incremental improvement for healthcare facilities to transport patients with IVs safer and more efficient. Our company has introduced a one of a kind wheelchair attachment, Dual Left and Right Arm IV Hooks and Overhead Anti Theft Device
Austin Innovation Group
We help companies solve complex problems in biotechnology. For more information, see https://AustinInnovationGroup.com
Trade Promotion Agency of Costa Rica – PROCOMER
The Trade Agency of Costa Rica-PROCOMER with base in Houston, Texas is a government entity that facilitates free of charge services to connecting with Costa Rica´s contract manufacturers in industries such as Medical Devices, Electronics, Aerospace, Oil & Gas, Automation, and Software Engineers for supporting the development of enterprise and digital transformation projects, among others.… Continue reading Trade Promotion Agency of Costa Rica – PROCOMER
OsteoCentric Technologies
Founded in 2015, OsteoCentric collaborates with design surgeons to leverage the Unifi Mechanical Integration (UnifiMI) technology across orthopedics and dental. UnifiMI mechanically integrates with bone to provide instant and lasting multi-axial stability and load sharing in normal, compromised and osteoporotic bone.
Quality System Consulting
quality system consulting for medical devices quality audit (ISO 13485 and FDA QSR) FDA warning letter and 483 remediation
Jawad Ali, MD
I am a surgeon and medtech consultant here in Austin, TX. I graduated as the first class of surgeons under UT Dell Medical school! I’ve been working with start-up companies for over 10 years. Working with motivated teams to get ideas to the next stage, teams assembled, products to market, and fueling the next generation… Continue reading Jawad Ali, MD
TMDA-Company2
An alliance to serve the medical device community of Texas
Obelix Biotech Solutions (Obelix Consulting LLC)
Pragmatic medical device regulatory and quality solutions to meet US, CA, EU compliance requirements. Pre-Sub/IND, 513(g), 510(k)/DeNovo for CDRH/CBER, Breakthrough Services Program, Safer Technologies Program, EU Technical File/Dossier, QSR/ISO 13485 implementation/audit/remediation