O'Connell & Myers was established in 2018 with the goal of helping start-ups and small medical device companies navigate the FDA's regulatory process to get their first FDA clearance or approval, to set up their Quality Management Systems, or to assist manufacturers who lack expertise in the design control aspect of regulatory affairs.
In addition we specialize in helping international manufacturers and distributors obtain the FDA approvals necessary to introduce their medical devices into the United States market.
When you choose to work with O'Connell & Myers, we know that the devices that enter the marketplace will carry your reputation as well as ours. This is a matter that we take extremely seriously because we are only successful when you are successful.
Company Details
- Employees
- 1
- Founded
- -
- Address
- Dallas , Texas 75009, Us
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- http://www.oconnellmyers.com
- Keywords
- Medical Device Regulatory Affairs, Medical Device Quality Systems, FDA Submission, EU Submission, FDA Device Class 1, 2 & 3, Quality Auditing, Design Controls, 21 CFR 820, ISO 13485, FDA Pre Market Submissions, Medical Device, Device Listing, Establishment Registration, Device Labeling, Quality System Regulations, EU MDR, Remediation, 510(k), Regulatory Consulting, UDI.
- HQ
- Dallas , Texas
O'connell & Myers, Llc Questions
O'Connell & Myers, Llc's website is http://www.oconnellmyers.com
O'Connell & Myers, Llc's LinkedIn profile is https://www.linkedin.com/company/oconnellandmyers
O'Connell & Myers, Llc has
1 employees.
View email and phone details for 1
employees at O'Connell & Myers, Llc.
O'Connell & Myers, Llc's industry is
Medical Equipment Manufacturing
O'Connell & Myers, Llc's top competitors are
Ssi Strategy,
Valinor Pharma (Acquired By Grünenthal),
Eqt Group,
Grünenthal Group,
Medicept Inc.,
Cantel Medical,
Genedx.
O'Connell & Myers, Llc's categories are Medical Equipment Manufacturing
O'Connell & Myers, Llc's founding year is 2018
