Highland Biomedical aids medical device (including IVDs) and combination product manufacturers through expert consulting, training, and guidance throughout the development process. Drawing upon over 15 years of expertise, our services have effectively bolstered numerous medical devices across the entire product lifecycle. To ensure the success of each manufacturer, we customize our offerings to align with your short- or long-term requirements. This can entail fractional positions or on-call, hourly consulting contracts, tailored to guide and execute according to your budget.
Our team offers a comprehensive suite of services, encompassing regulatory and quality consulting, clinical trial review, statistical analysis and assessment, and comprehensive clinical trial support.
Quality
In the complex landscape of medical device development, ensuring product quality is paramount. At Highland Biomedical, our quality consulting services are designed to help you establish and maintain a robust quality management system (QMS) that complies with global regulatory standards, including ISO 13485 and 21 CFR Part 820. Our team of seasoned experts provides comprehensive support to implement and optimize your QMS, ensuring that all processes, from design and development to production and post-market surveillance, meet the highest standards of quality and safety.
Clinical Trial and Statistical Support
With the increasing complexity of medical devices, there is a growing need for clinical trials to bolster regulatory submissions. Our team offers comprehensive support for clinical protocol review to ensure conformity with regulatory standards. Additionally, we provide thorough review and analysis of statistical methodologies pertinent to clinical studies.
In cases of intricate studies, we excel in facilitating and spearheading interactions with regulatory bodies, including but not limited to Pre-Submissions and Investigational Device Exemptions.
Regulatory
Navigating the pathways to market authorization for medical devices involves a clear understanding of the Federal Food, Drug, and Cosmetics (FD&C) Act. To initiate this process effectively, our consulting team routinely recommends developing a regulatory strategy. Identifying the appropriate regulatory pathway for your device is crucial for refining business strategies and aligning with short-term and long-term goals.
Following the formulation of a regulatory strategy, the subsequent step often entails regulatory submissions. Our team has facilitated numerous successful FDA and notified body submissions, including:
• Pre-Submissions
• 513(g) Requests
• 510(k) Premarket Notifications
• De Novo Requests
• Premarket Approvals
• Breakthrough Device Designation Requests
• Safer Technologies Program Entrance Requests
For many of our clients, we provide comprehensive support throughout the entire product lifecycle, extending beyond the initial stages. Upon obtaining marketing authorization, we continue to assist manufacturers by reviewing the regulatory impact of device modifications, preparing letter-to-file documents, and facilitating new submissions.
We also have extensive expertise with notified bodies outside of the United State (OUS). We have successfully support numerous technical files, classification statements, and interactions.