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Medical Device Consultants LLC
医疗设备制造业
Salt Lake City，Utah 218 位关注者
Quality Management System | Risk Management | Audit | Remediation | Design Controls
关于我们
Medical Device Consultants LLC is a consulting firm specializing in providing support to medical device companies in Quality Management System implementation and maintenance, quality compliance, supplier management, supplier/internal audits, design controls, risk management, gap assessment and remediation activities.?
- 网站
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https://www.meddevconsultants.net
Medical Device Consultants LLC的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 1 人
- 总部
- Salt Lake City，Utah
- 类型
- 自有
- 创立
- 2019
- 领域
- Risk Mangement、CAPA、QMS Development、ISO 9001、ISO 13845、ISO 14971、Design Controls、Internal Audit、Supplier Audit和Quality Events
地点
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主要
获取路线
US，Utah，Salt Lake City
动态
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FDA had issued their final ruling to retain the scope of 21 CFR 820 but update several of it provisions to align with and point to ISO 13485. This is will reduce greatly the administrative burden on start-ups of compline with multiple regulations. This enhance competition and remove barriers to new markets. This updated QMSR will have emphasis on a risk-based approach for product, process development and overall decision making. #medicaldevices #iso13485 #startup #qms
The FDA remains committed to ensuring #MedicalDevices on the market are safe, effective, and of quality. Today we issued the Quality Management System Regulation Final Rule, amending the quality system regulation (21 CFR 820). This final rule is intended to emphasize risk management and risk-based decision-making principles and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.?https://lnkd.in/dzhgXR-R
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In the digital lives that we all lead, we come across multi-factor authentication on a regular basis. This is a great way to explain it with an analog example...
Read every textbook you want, this is by far the best explanation of Multi-Factor-Authentication (MFA) for non-technical folks that I’ve ever encountered. ?? And boy would I be mad if I moved into that apartment and found it like that. ?? Happy Friday.