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ISO 13485 vs ISO 9001: Key Differences

Regulatory Compliance

September 27th, 2024

10 min read

ISO 13485 and ISO 9001 are both quality management system (QMS) standards, but they serve distinct purposes within different industries.  While ISO 9001 provides a generic framework for quality management, ISO 13485 is specifically tailored to the medical device sector. Both standards share fundamental principles centered on customer satisfaction, process-based approaches, and continual improvement. Organizations...

How ISO 13485 Boosts Medical Device Quality

Medical Device Manufacturing

September 13th, 2024

10 min read

The medical device industry balances innovation with patient safety. At the center of ensuring the reliability and effectiveness of these devices is ISO 13485, a globally recognized standard for quality management systems (QMS).  This standard provides the framework for medical device manufacturers to implement and maintain processes that prioritize patient safety and product quality. Let’s...
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Pass Your ISO 13485 Audit with This Checklist

Audit

September 2nd, 2024

10 min read

Navigating the complexities of ISO 13485 can be overwhelming for medical device manufacturers. This international standard sets the benchmark for quality management systems (QMS) in the medical device industry, ensuring product safety and efficacy.  We’ve created a comprehensive ISO 13485 audit checklist to help you streamline your audit process and improve your chances of compliance....

The Future of AI in Life Sciences

Artificial Intelligence

August 16th, 2024

10 min read

In our previous posts, we discussed the evolution of quality management systems (QMS) and AI tools and technologies that are accelerating quality in the life sciences industry. In this third and final installment, we take a look forward with Harsh Thakkar, Qualitvate CEO, to explore future trends in AI within the life sciences and challenges...

Guide to AI-Powered Quality Management for the Life Sciences Industry

Artificial Intelligence

August 9th, 2024

10 min read

In our previous post, we explored the evolving landscape of quality management systems (QMS) in the life sciences industry and how AI is transforming these systems. This post will dive deeper into specific AI tools and technologies that enhance quality in the life sciences industry. Read on as we look into AI-powered quality solutions with...

From Manual to AI-Driven: How Quality Management in the Life Sciences Has Evolved

Artificial Intelligence

August 5th, 2024

10 min read

Electronic quality management systems (eQMS) are essential in ensuring product safety, efficacy, and compliance across the life sciences industry. However, as the industry evolves, so must these systems. This blog post, along with insights from Harsh Thakkar, CEO of Qualtivate, will explore how AI innovations are transforming quality management in the life sciences sector. First,...

Fireside Chat: Timing is Everything in Life Sciences and Manufacturing Investments

Inside dot

July 25th, 2024

10 min read

Welcome everyone to today’s fireside chat. Dot Compliance is thrilled to be joined by three esteemed guests from one of our partners, West Monroe, a digital services firm that blends management consulting, digital design, and product engineering to move companies from traditional ways of working to digital operating models. Our guests are Steven Lupo, a...

10 Reasons eQMS Solutions are Critical in Pharma

Pharmaceutical Manufacturing

July 12th, 2024

10 min read

Implementing an electronic quality management system (eQMS) is crucial for organizations in the pharmaceutical industry. These systems are designed to help pharma companies comply with regulatory requirements and standards such as 21 CFR Part 11, ISO 14971 as well as guidelines set forth by regulatory agencies like the US Food and Drug Administration (FDA) and...