Ensuring the safety and efficacy of healthcare products is of utmost importance. The clinical evaluation process of medical devices is vital for demonstrating the device’s safety and performance in accordance with the regulatory requirements. How are device makers navigating this complex process effectively.
The call for abstracts for the MTI Regulatory Intelligence and Networking Summit is now open. The Summit, which will be held June 3-5, 2024, Washington, DC, offers education and discussion for the Medtech community as it works to develop processes, procedures and solutions to streamline global and product lifecycle regulatory compliance.
Karandeep Badwal, consultant and president of QRA Medical, discusses the change in focus from EU MDD to EU MDR, and how companies will need to adapt to meet new reporting requirements and maintain compliance in the European market.
For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists, turns and roadblocks. This article examines some of the major challenges to bringing digital health products to market and explores potential opportunities to ease the journey.
The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
By deploying connected intelligence systems at a global scale, teams can navigate go-to-market challenges by increasing the transparency and predictability of the complex and divergent global product registration processes.
Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
Life sciences companies have a lot of factors to consider when it comes to labeling. Understanding the global labeling regulations for patient safety and how enterprise labeling solutions can help companies achieve compliance while assuring speed to market, and labeling system validation and auditability, can save resources and reduce costly errors.
The deeper insights provided by a single source of truth help regulatory teams pinpoint and address gaps in data collection during each trial phase. By mitigating potential risks earlier in the process, teams generate more robust evidence and stronger submissions, which often means a shorter approval process.
