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- Medical Device Regulatory Compliance Software | Arena
To ensure patient safety, medical device manufacturers must establish and maintain quality systems to meet regulatory compliance requirements specified by the FDA, EU MDR, ISO, and other regulatory bodies Adhering to regulations like the FDA’s 21 CFR part 820 and ISO 13485 are key to your commercialization success
- Regulatory Management Software For Medical Devices
In the highly regulated medical device industry, quality and compliance are non-negotiable ISO 13485, the international standard for Quality Management Systems (QMS) in the medical device industry, plays a critical role in ensuring that manufacturers meet regulatory requirements for medical devices and in-vitro diagnostic products
- Medical device compliance | Siemens Software
Achieving regulatory compliance during medical device development requires a holistic approach where quality and compliance complement each other This can be done in a two-step process The first is implementing a quality management system (QMS) that accelerates product development and reduces time-to-market
- Medical Device Life Sciences Development Software | Jama Connect
Simplify regulatory submissions and compliance with industry standards; Support Multiple and Hybrid Product Development Processes (PDP) It is built to include standard medical device frameworks that support key medical device software standards and regulations, including: Regulatory Agencies: FDA 21 CFR 820 30, 21 CFR 11, EU MDR, EU IVDR;
- Medical Device QMS Software to Accelerate Time to Market
ETQ Reliance® QMS for medical devices accelerates compliance, ensures ISO 13485, 21 CFR Part 11, and GMP readiness, helping bring products to market faster The best QMS software for medical devices ensures compliance with regulatory requirements like GMP, 21 CFR Part 11, ISO 13485, eMDR electronic submissions, and system validation
- Software as a Medical Device (SaMD) - FDA
Such software was previously referred to by industry, international regulators, and health care providers as "standalone software," "medical device software," and or "health software," and can
- Emergo by UL | Medical Device, IVDR Compliance and Human Factors
From discovering your users’ needs to navigating post-market compliance, partner with Emergo by UL Our medical device regulatory consultants and human factors experts in more than 20 countries can help you improve your medical device designs, guide you through global regulations, and prioritize markets for new product growth
- Medical Device QMS Software | Regulatory Compliance Solution
LuminLogic is a fully configurable medical device QMS and regulatory compliance software for complete product lifecycle development This software helped us stay on track with the FDA requirements, leading to a faster approval process Sven Erdmann Vice President Technology and Regulatory, Ulrich Medical
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