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FDA Consultant, Medical Device Regulatory Affairs, CE Mark, EU MDR, Quality Auditing, Compliance, and CER Support for your company
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Nosotros hablamos español. Falamos portugues.
FDA Regulatory Submissions and Registrations
510(k) Submissions to FDA, Emergency Use Authorizations for COVID-19, Pre-subs, Establishment Registrations, Device Listings, UDI, International Registrations (Latin America, Asia, Eastern Europe, Middle East), EU CE Marking and Tech File/Design Dossier Creation and Maintenance. Clinical Evaluation Report (CER).
Regulatory and Quality Assessments and FDA Warning Letter and 483 Support
Allow us to Assess your Regulatory and Quality needs per ISO 13485 and FDA 21 CFR 820 Quality Systems Regulation
Quality Auditing, Audit Prep, and ISO 13485 : 2016 Gap Analysis, MDSAP, Internal Audit, External Audit Support and Remediation
Allow us to Audit your Quality System, prepare you for your next external audit, and support you during your next external audit by FDA, Registrar, Notified Body, ANVISA, or Other Authorities
Read what people have said
Dallas is very detail oriented. He is well organized and exceptional at documentation and follow up. He is self motivated and also functions extremely well working with teams. He looks to the future and is always looking at ways to improve both himself and whatever process he is working on. The thing that impresses me the most about Dallas is his ability to translate. He can effectively carry on bilingual conversations, while translating, without slowing the conversation at all. He is an exceptional asset to anyone looking to do business in Latin America. While I had the opportunity to work with Dallas, he handled all regulatory responsibilities for most of Latin America, Australia and all of EEA. He will be an asset to any company who is fortunate enough to work with him.
Dallas is a leader, mentor and creator of win-win solutions. He is a strategic thinker who looks to build and improve systems. He can handle stressful situations with an amazing amount of patience and grace while focusing on the issues while building respectful relationships at the same time. As a CE and International Medical Device Regulatory Affairs expert Dallas will have a results oriented positive impact on any organization.
Clients & Companies We've Worked With
We'll get your Quality System, Compliance & Product Registrations to the next level to increase efficiencies & reduce time to market while taking the least burdensome approach. Initial consultations are always free! Contact us now!
Medical Device Experience
We work with all medical device types and know the process and the tools in the regulatory submission toolbox. Below highlights some but not all of the medical device projects we have worked on. We welcome all medical device types to get you through the regulatory process smoothly and step by step. Reach out for a free consultation.
•Sterilization Devices for processing surgical and dental instruments (autoclave / heat / steam sterilizer machines)
*Emergency Resuscitator / Ventilators/ Face Masks / Surgical Mask/ Surgical Gown / N95 Respirators / PPE / Air Purifiers for COVID-19 SARS-CoV-2 Pandemic
•Software as Medical Device (SAMD)
•Software in a Medical Device
•Surgical Mesh devices
Cosmetic Medical Devices, hair growth devices, LED devices
•Syringes, Insulin Needles, Hypodermic Needles
•Gastroenterology Devices: Radiofrequency Ablation, Cytological Sampling
•Patient Spot Monitoring
•Electromedical: Vascular / Ophthalmic Ultrasound, Ultrasonic Tissue Cutting incl. some w/ Bluetooth & cybersecurity
•Orthopedic Devices: Spinal Fixation Systems, Rods, Plates, Nails, Screws, pediatric
•Stent Grafts: Thoracic, Aortic, balloon.
•Dental (incl. implants, restorative abutments, surgical tools, digital, custom, mouthpiece, & regenerative allograft bone)
•Mouthpiece: snoring, obstructive sleep apnea - OSA
•Vascular Access: Implantable Infusion Port - Catheter, Infusion Needle Sets, Vascular Ultrasound, Catheters (PICCs, Dialysis, Drainage), Feeding Tubes
•Absorbable and Non-Absorbable Sutures
•Ophthalmic Ultrasound (electromedical)
•Vision Care Devices i.e. contact lenses
•Biosensor devices (i.e. oximeters, etc.)
•Wound Care devices
•Multi-vital sign / spot checking monitoring system / blood pressure / pulse oximeter / biosensor / heart rate
•Surgical equipment: reusable surgical instruments, handpieces, motors, ultrasonic tissue removal devices
We are here to help with your FDA and Medical Device Needs. Just reach out!
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Finding a trusted & frank medical device consulting company at an affordable rate can be difficult.With rapidly changing regulatory, quality, & clinical evaluation requirements, it can be difficult to keep up.Years ago I started my career & soon realized my passion in regulatory & quality.To cut your regulatory & quality costs over the long term requires the right client-consultant fit. I've worked w/ device companies across the country & internationally in training, guiding on varied medical products including low to high risk devices in areas of dental, neuro-surgical, vascular access, ultrasound, stent grafts, sutures, ophthalmic & vision care, biosensors, & wound care among others.Message me for a free consult!
We are hands-on strategy developers, information hunters, life-long learners & connected team players. We seek to improve existing processes for maximum productivity, taking a lean approach to reduce costs. We believe in seeking the most robust & sound regulatory & quality & compliance solutions & strive to be attuned to find the least burdensome approach within due bounds for clients.We believe in being approachable & transparent in assisting my clients in any concerns.We are here to help answer your questions & provide guidance in navigating the complex regulatory & quality space. Our intrinsic ethics & values instilled in us are of the highest caliber & we believe in dialogue,mutual input & respectfully maintaining the relationship intact in disagreements.As we've been in this industry for most of our careers, we're confident in our abilities to assist you as we have w/ others.We understand your challenges and how to bring solutions.
Based in Florida, USA