In addition to the demands associated with device approval, the costs associated with certifying and maintaining an FDA-compliant facility can be prohibitive and require a great deal of experienced personnel. Being able to trust a manufacturing partner, such as an electronic manufacturing services provider that specialises in medical devices, may allow a company to focus on its core strengths, while also helping with regulations. Medical EMSs have FDA-registered factories and are regularly audited for compliance by a notified body.If your business is well established, you'll likely be familiar with the process of developing a medical product, preparing documentation, and meeting regulatory and manufacturing requirements. If not, then the following key points may provide some guidance on navigating the development and release process in practical terms.
Medical device companies must assess the type of certification required for FDA approval. Determining the type of FDA application to file is critical. If a PMA is required, the medical device company must complete the clinical trials, documentation, risk assessments, and other requirements. If there is a predicate device on the market and the product can go to market with a 510k, or if pre-market approval has been achieved, then an experienced medical design firm can be of significant help.The same company also can develop a more robust supply chain, an important consideration given that most medical products and devices have a longer life in the market than other products. Also, the FDA requires products to be supported for an extended period of time even after they are no longer for sale in the marketplace.
EMS and design companies experienced with medical product design and documentation can leverage prior experience with medical device design, manufacturing, supply chain management, and FDA regulatory requirements.For a smaller company, establishing a 13485-2003-certified medical facility requires a substantial investment. A larger company may not have a certified or FDA registered facility in the right location. Both small and large companies should strongly consider finding a manufacturing partner to assist with manufacturing in the location that meets the needs for technology, supply chain and duties, or tariffs.
Medical device companies must assess the type of certification required for FDA approval. Determining the type of FDA application to file is critical. If a PMA is required, the medical device company must complete the clinical trials, documentation, risk assessments, and other requirements. If there is a predicate device on the market and the product can go to market with a 510k, or if pre-market approval has been achieved, then an experienced medical design firm can be of significant help.The same company also can develop a more robust supply chain, an important consideration given that most medical products and devices have a longer life in the market than other products. Also, the FDA requires products to be supported for an extended period of time even after they are no longer for sale in the marketplace.
EMS and design companies experienced with medical product design and documentation can leverage prior experience with medical device design, manufacturing, supply chain management, and FDA regulatory requirements.For a smaller company, establishing a 13485-2003-certified medical facility requires a substantial investment. A larger company may not have a certified or FDA registered facility in the right location. Both small and large companies should strongly consider finding a manufacturing partner to assist with manufacturing in the location that meets the needs for technology, supply chain and duties, or tariffs.
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