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.
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.
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.
Today we’re exploring the all-important IEC 62304 standard. This isn’t just another regulatory hoop to jump through—this standard is the backbone of how medical device software is developed, maintained, and kept safe. It’s the unsung Read more…