The Importance of Third-Party Compliance Auditing in the Medical Device Design Industry
Third-party compliance auditing plays a vital role in the medical device design industry. It ensures that companies adhere to regulatory...
The Latest FDA Device Software Guidance: What You Need to Know
The Latest FDA Device Software Guidance provides important information for manufacturers and developers of medical device software. This...
Understanding the Importance of Quality Management in the Medical Device Industry
Quality management plays a crucial role in the medical device industry to ensure the safety and effectiveness of medical devices. It...
Uncovering the Challenges in the Medical Device Industry
The medical device industry faces numerous challenges that must be addressed to ensure the safety and effectiveness of devices. From...
Uncovering the Challenges Faced by the Medical Device Industry
The medical device industry faces numerous challenges that impact its ability to deliver safe and effective products. These challenges...
Mastering the Certification Process: Achieving PMAs and 510(k)s
Mastering the certification process for PMAs and 510(k)s is crucial for medical device manufacturers to ensure compliance with regulatory...
How to Use Regulatory Strategy to Reduce Medical Device Time-to-Market
Regulatory strategy plays a crucial role in reducing the time-to-market for medical devices. By understanding and navigating the complex...
Understanding the Importance of CE Marking for Medical Devices
CE marking is a crucial certification for medical devices in the European market. It indicates that a product meets the necessary...
Understanding the Proposed FDA Medical Device Quality Control Regulations
The proposed FDA medical device quality control regulations aim to enhance patient safety and improve product quality and reliability....
The Future of Medical Device Manufacturing: 3D Printing at the Point of Care
The future of medical device manufacturing is being revolutionized by 3D printing technology. With its ability to create customized and...
Changes in FDA Medical Device Regulation for 2022
The FDA has implemented several changes in medical device regulation for 2022 in order to enhance patient safety and improve the overall...
Understanding Medical Device Safety Standards: A Comprehensive Guide
Medical device safety standards play a crucial role in ensuring the safety and effectiveness of medical devices. These standards are...
Questions to Ask Before Hiring a Medical Device Outsourcing Company
Before hiring a medical device outsourcing company, it is important to ask the right questions to ensure that they are the right fit for...
The Integration of Artificial Intelligence in Medical Devices
The integration of artificial intelligence (AI) in medical devices has revolutionized the healthcare industry. AI technology has the...
Top Pitfalls to Avoid with Smartphone Medical Devices
Smartphone medical devices have become increasingly popular for monitoring health conditions and managing medical treatments. However,...
The Importance of Software Design in Medical Devices
Software design plays a crucial role in the development of medical devices. It ensures patient safety, compliance with regulatory...
Understanding FDA's New Guidance for Cybersecurity in Medical Devices
The FDA has recently released new guidance for cybersecurity in medical devices. This guidance aims to address the growing concerns...
Recent Updates in ISO 10993-17:2023
ISO 10993-17:2023 is a standard that provides guidelines for the evaluation of medical device biocompatibility. It specifies the...
Avoiding Common Mistakes in Medical Device Startups
Starting a medical device startup can be a challenging and complex process. From choosing the right market to securing funding and...
The Importance of Human Factors Engineering in Combination Product Development
Human Factors Engineering (HFE) plays a crucial role in the development of combination products. By considering the interaction between...
The Importance of Tying PMS and PMCF Requirements to Risk Management
Risk management plays a crucial role in the development of medical devices. It involves identifying, assessing, and mitigating potential...
Exploring the Power of Computational Modelling and Simulation in Medical Technology
Computational modelling and simulation have revolutionized the field of medical technology, offering numerous advantages in various...
Exploring the Future of Medical Technology Development
The future of medical technology development holds immense potential for revolutionizing the healthcare industry. Advancements in...
The Roadmap to Successful Medical Device Commercialization
Successfully commercializing a medical device requires careful planning and execution at every stage of the process. From understanding...