Ketryx raised $14 million in Series A funds. The startups sells a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams.
RPM has ushered in a new era of healthcare. However, navigating the complexities and challenges of this landscape requires a thoughtful QA strategy.
In a recent interview, Esperion president and CEO, Sheldon Koenig talks about the reality of statin intolerance and his company’s expansion into new diseases
Ensuring Quality is the best first step any company, especially startups, can take steps toward preparing for future changes to LDT regulations. Hire and lean on your quality expert to formalize documents to meet requirements, find gaps in best practices, and utilize internal audits to verify standards are being followed.
Having a streamlined process to get customer feedback, adhere to regulations, and automate processes not only helps make sure a business delivers the best quality products, but also helps ensure that customers are satisfied.