Orcanos – Adaptive compliance software to support the ever changing medical...
Overview As a startup in the medical device industry, it can be challenging to navigate the ever-changing landscape of regulations and market demands. As your company grows and evolves, your software...
View ArticleDifferences between quality control and quality assurance
Quality control (QC) and quality assurance (QA) are two important concepts in any production or manufacturing process. Although both terms are related to ensuring quality in products, they differ in...
View ArticleDriving Safety and Efficiency in Medical Device Development: The Growing Role...
In the world of medical device development, staying up-to-date with technology and best practices is essential. The use of Application Lifecycle Management (ALM) tools has become increasingly popular...
View ArticleCapa management in pharmaceutical industry
In the pharmaceutical industry, the implementation of a robust Corrective and Preventive Action (CAPA) management system is crucial for ensuring product quality and patient safety. The pharmaceutical...
View ArticleThe ultimate guide to QMS digital transformation
The Opportunity The digital transformation has profoundly impacted virtually every industry, and the medical device industry is no exception. Medical devices perform specific functions such as...
View ArticleFDA approves a framework similar to Orcanos that simplifies the CAPA process...
The FDA has approved a new risk-based approach for the CAPA process. According to an FDA official, this tool can assist medical device manufacturers in addressing their most crucial issues first. The...
View ArticleBest Practices for Codification in Product Development
In the fast-paced world of product development, efficient and effective communication is vital for success. Codification is crucial for clear and consistent communication within product development...
View ArticleHow to Build Safer and More Reliable FDA-Approved Software
Importance of High-Quality Software for Business Success The impact of software innovation on our world is truly remarkable! It addresses significant challenges, streamlining processes and enhancing...
View ArticleEmbracing the Future: The Imperative Need for a Robust QMS System in the...
Introduction In the dynamic and highly regulated medical device industry of 2023, ensuring patient safety, meeting strict quality standards, and complying with complex regulations are paramount. In...
View ArticleTop 10 questions you need to ask any eQMS vendor for ensuring Regulatory...
Introducing Orcanos: Ensuring Regulatory Compliance Orcanos is a leading provider of innovative solutions for ensuring regulatory compliance in the medical device industry. With a strong focus on...
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