LAMBINT, LLC
Medical Device Regulatory Affairs Consulting
Streamline Compliance and Accelerate Market Entry with Expert Medical Device Regulatory Consulting
Streamline Compliance and Accelerate Market Entry with Expert Medical Device Regulatory Consulting
Partnering with our regulatory consulting group gives you confidence that your business is meeting all relevant regulatory requirements. We leverage years of experience and deep industry knowledge to provide practical and customized solutions that minimize risk and optimize compliance processes. We help you navigate complex regulatory frameworks, stay current on evolving regulations, and provide continuous support to meet your regulatory needs. As a small firm, we are easily accessible for quick responses to your regulatory needs.
At the intersection of where health tech innovation meets regulatory requirements Get-to-Market Health had the good fortune to work with Roaida Johnson of Lambint. Ro is extremely knowledgeable, collaborative, experienced in the intricacies of global medical device approval, and attentive to the impact of regulatory on commercial operations. It was a pleasure working with Ro as she drove regulatory approvals in the US, UK, EU, and APAC.
Steve Shihadeh - Founder
MP Brock Zimmerman - Partner
Get-to-Market Health
As the Chief Commercial Officer of CREO Medical Ltd and acting General Manager of CREO Medical Inc.
in the US, I needed strong RAQA leadership in the United States. Roaida Johnson helped develop our US
and international strategy for Medical Devices submission and approvals providing guidance on US FDA
requirements and new European requirements. Her experience and leadership in regulatory and quality
were also essential in the development of our regulatory SOPs, documentation, and the overall quality
system in the US. I highly endorse Roaida for any company looking for RAQA leadership or support
based on her expertise, diligence, and character. She is a pleasure to work with and a great resource.
David Woods - CCO
Creo Medical Ltd
Roaida Johnson is my first call when we are facing a demanding or new regulatory challenge. She has an innate talent to quickly assess the situation and provide carefully considered strategic alternatives for our project needs. Roaida’s extensive Regulatory knowledge in the medical device industry makes her an asset for supporting program initiatives, developing QA/RA teams and guiding executive leadership.
Jenny Harris - Sr. Director Quality & Regulatory
Hyperfine, Inc.