Case Study
Welcome to our collection of case studies, where theory meets practice in the realm of FDA compliance. At Complianceglobe, we pride ourselves on navigating the complex landscape of FDA regulations, ensuring that medical devices and cosmetics not only meet but exceed the stringent standards set forth by the FDA. These case studies demonstrate our commitment to excellence and the tangible success our clients experience in their compliance journeys.
General Info
Complianceglobe consulting service(s) referenced in this case study: Medical device classification, Medical device licenses (MDLs), Medical Device Establishment Licenses (MDEL)
CPAP mask is intended for use in the home or hospital/institutional environment on patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy
The medical device manufacturer and their Canadian distributor commissioned our services to develop and implement a comprehensive Health Canada regulatory compliance strategy for their devices.
We delivered and managed the entire project to develop and implement a ‘Health Canada Regulatory Compliance Solution’ for the clients. The key deliverables
- Classification of the medical devices as per Health Canada regulations
- Medical device license (MDL)
- Medical device establishment license (MDEL)
General Info
Complianceglobe helps a west coast medical technology company obtain the MDR certificate in shortest time
Clients need to obtain the MDR certificate in the shortest possible time
Complianceglobe’s clients develop and implement MDR-compliant compliance departments. complianceglobe provides clients with expert MDR compliance specialists to guide and train clients on the technical documentation of their products, including clinical assessment reports and risk management reports, and after the initial assessment, helps clients specify a detailed MDR compliance audit program. After the initial assessment, we helped the client to design a detailed MDR compliance audit program. With the support of designated internal resources, our consultant initiated the implementation phase by revising the safety/surveillance SOPs, risk management documents, and helped the client successfully pass the audit by the NB organization and obtain the MDR audit certificate.
Complianceglobe has a very professional team to help our clients obtain their MDR certificates and save them a lot of time and effort
General Info
Complianceglobe helps cosmetic brand transformation through FDA compliance
A cosmetic company struggling with FDA compliance due to ingredient and labeling issues risked their brand reputation and market presence
Our experts conducted a thorough review of the product formulations and labeling, implementing a strategic compliance plan to align the brand with FDA requirements
The brand successfully revamped its product line, regained consumer trust, and expanded its market reach, establishing itself as a leader in safe and compliant cosmetics
General Info
Complianceglobe navigates complex 510(k) Submission for a wearable medical device
A startup specializing in wearable medical technology faced challenges in navigating the 510(k) submission process for their groundbreaking device
Complianceglobe provided end-to-end guidance, from regulatory strategy development to submission support, ensuring that every aspect of the device met FDA compliance standards
The device was approved within a significantly reduced timeframe, allowing the company to launch their product to the market faster, revolutionizing patient monitoring and care