Imagine a world where diseases are not just treated but predicted, where food scarcity is a thing of the past, and where the environment heals with the help of microscopic allies. Sounds like science fiction? Welcome to the future of BioTech! Let's embark on a journey through the global trends shaping the BioTech industry and […]

Medical device manufacturers play a critical role in healthcare, and while they strive for innovation and compliance, there are several areas where they often miss the mark or could improve: 1. User-Centered Design: Problem: Medical devices sometimes lack intuitive interfaces and user-friendly designs, which can lead to user errors, especially in high-stress environments like hospitals. Improvement: Manufacturers […]

Quality management in the medical device industry is critical to ensure the safety, efficacy, and compliance of products. Here are some best practices in quality management for this sector: ISO 13485: This international standard specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and […]

Quality management in the medical device industry is particularly critical due to the potential impact on patient safety and regulatory requirements. In order to assist you, we put together this list, with some common pitfalls to watch out for: Inadequate Design Controls: Insufficient Risk Management: Poor Supplier Quality Management: Inadequate Corrective and Preventive Actions (CAPA): […]