Bringing life-enhancing medical devices safely and efficiently to patients: A guide
25 Jun 2023
To remain competitive in the medical device market, manufacturers need to be able to offer innovative, high-quality, safe, and effective devices for patients whilst meeting strict standards and regulations. On top of this, manufacturing demands constant insight into renewable resources, sustainable materials, equipment that is more energy efficient, and methods to reduce waste.
This eBook provides an overview of medical device quality control and manufacturing solutions for the entire development and production process to help fulfill biocompatibility, cleanliness, safety, and packaging standards.
This expert guide will also outline:
- Compliant lab weighing and pipetting
- The importance of ultrapure water
- Reducing the risk of endotoxin contamination
- Viable air monitoring in sterile production environments
- Live-cell imaging for cytotoxicity evaluation
- More efficient lateral flow assay development
- Streamlined measurement of product attributes during biotherapeutic development
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Shipping / PackagingPackaging is the technology of enclosing or protecting products for distribution, storage, sale, and use and the process and production of packages. Packaging is closely linked to Shipping and the preparing of goods for transport, warehousing, logistics, sale, and end use. Within the pharmaceutical industry packaging and shipping are used for transport, storage and logistics between Contract Research Organizations (CROs), Manufacturing and Clinical Trial companies. Packaging is also critical in the final production of a pharmaceutical product before market. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. Lateral Flow AssaysManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.


