Technology – Wiselink

6月252023 by 管理No Comments

TGA Registration Services

Technology

The Therapeutic Goods Administration (TGA) provides information on therapeutic goods that can be supplied in Australia via the Australian Register of Therapeutic Goods (ARTG). To make your medical devices a legal medical supply in Australia, you must register your medical device with the TGA to be included in the ARTG.After obtaining registration with the TGA, your medical device can be lawfully supplied in, imported into or exported from Australia, which will provide further benefits and enhanced business performance for your company. Why Choose Us? At Wiselink, we use our expertise to help you save time and resources. We will get your medical device approved, registered and listed in the ARTG within the shortest timeframe possible. We provide full service for the...

Quality Management System Services

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We have highly experienced expertise to give you reliable consultancy and efficient service. Adopting a certified quality management system provides your organisation with a strong foundation of performance optimisation, brand transparency and continuous improvement. ISO 13485: Medical Devices Quality Management Standards FDA QSR: Compliance for Medical Device Manufacturers MDSAP: Medical Device Single Audit Program

FDA: Compliance of Medical Device Manufacturers

Technology

What Is It? The FDA QSR is a set of Quality System Regulations defined by the U.S. Food & Drug Admission. All medical device manufacturers are required to establish and maintain a quality system that meets the legal requirements prescribed in 21 CFR Part 820. Under this legislation, there are 14 subparts to ensure quality and safety throughout the design and manufacturing process of the medical devices: General Provisions Quality System Requirements Design Controls Document Controls Purchasing Controls Identification and Traceability Production and Process Controls Acceptance Activities Nonconforming Products Corrective and Preventive Action Labeling and Packaging Control Handling, Storage, Distribution and Installation Records Servicing ...