Environmental, Social, and Governance (ESG) Metrics: Integrating Sustainability into Quality Management for a Better Future
Environmental, Social, and Governance (ESG) Metrics: Integrating Sustainability into Quality Management for a Better Future
In the rapidly evolving landscape of the biotech industry, companies are increasingly recognizing the importance of aligning their operations with global sustainability goal
Remote Quality Audits: Embracing Technology for Efficient and Effective Compliance in a Globalized Biotech Landscape
Remote Quality Audits: Embracing Technology for Efficient and Effective Compliance in a Globalized Biotech Landscape
In the ever-evolving world of biotechnology, ensuring compliance and maintaining the highest quality standards is of utmost importance. As companies expand their operations across
Patient-Centric Innovations: Transforming Clinical Trials for Enhanced Participant Experience and Outcomes
Patient-Centric Innovations: Transforming Clinical Trials for Enhanced Participant Experience and Outcomes
The landscape of clinical trials is undergoing a profound transformation, with a growing emphasis on patient-centricity and the integration of cutting-edge technologies. As the biotech indus
Training and Certification: Empowering Quality Professionals for Success in the Evolving Biotech Landscape
Training and Certification: Empowering Quality Professionals for Success in the Evolving Biotech Landscape
In the rapidly advancing field of biotechnology, the role of quality professionals is becoming increasingly critical. As the industry navigates complex regulatory requirements, stringent qua
Demystifying GCP and ISO 14155
Demystifying GCP and ISO 14155: Essential Quality Requirements for Clinical Trials
Clinical trials are the cornerstone of medical advancement, the critical bridge between laboratory discoveries and accessible patient treatments. They are complex undertakings, involving human participants, rigorou
ISO 13485 Explained
ISO 13485 Explained: Building a Robust Quality Management System for Medical Devices
The medical device industry operates under intense scrutiny, and for good reason. The products developed and manufactured within this sector directly impact human health and well-being. Ensuring the safety, effec
The Synergy of GCP and ISO 14155
The Synergy of GCP and ISO 14155: Ensuring Quality and Ethics in Medical Device Clinical Investigations
Clinical investigations are indispensable for demonstrating the safety and performance of medical devices. Unlike pharmaceuticals, medical devices often have different risk profiles, modes of a
Beyond Compliance
Navigating the Audit Landscape: Preparing for GCP, ISO 14155, and ISO 13485 Audits
Audits are an intrinsic part of operating within the highly regulated medical device and pharmaceutical industries. Whether conducted by regulatory bodies (like the FDA, EMA, or national authorities), notified bodi
The Role of Effective QA Training in Maintaining Compliance and Quality
Training for Excellence: The Role of Effective QA Training in Maintaining Compliance and Quality
In the highly regulated realms of medical devices and pharmaceuticals, the quality and compliance of products and processes are paramount. While robust Quality Management Systems (QMS), stringent prot
How ISO 13485 Impacts the Entire Medical Device Lifecycle
From Design to Post-Market: How ISO 13485 Impacts the Entire Medical Device Lifecycle
The journey of a medical device, from a nascent concept to widespread clinical use and eventual obsolescence, is a complex and tightly controlled process known as the medical device lifecycle. Unlike many other
Key Principles of GCP and ISO 14155 in Practice
Ensuring Subject Safety and Data Integrity: Key Principles of GCP and ISO 14155 in Practice
Clinical trials are the vital engine of medical progress, translating scientific discoveries into new treatments and diagnostic tools that can improve and save lives. However, conducting research involving
A Strategic Decision for Medical Device and Pharma Companies
Choosing the Right QA Partner: A Strategic Decision for Medical Device and Pharma Companies
Operating within the medical device and pharmaceutical sectors demands unwavering adherence to stringent quality and regulatory standards. Navigating the complex landscape of Good Clinical Practice (GCP),
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