…must address safety issues, including severe pelvic pain and organ perforation. Companies will have 30 months to submit a PMA for surgical meshes that are already on the market. New…
…must address safety issues, including severe pelvic pain and organ perforation. Companies will have 30 months to submit a PMA for surgical meshes that are already on the market. New…
…in the product specification. Global regulatory bodies allow the commercial release of product following all appropriate testing and clearances, with accelerated aging data. This compromise allows manufacturers to bring life-saving…
…in the product specification. Global regulatory bodies allow the commercial release of product following all appropriate testing and clearances, with accelerated aging data. This compromise allows manufacturers to bring life-saving…
…design verification testing separately from the package design verification testing. This paper suggests a partial combination of functional product and dummy product to demonstrate the package is capable of protecting…
…design verification testing separately from the package design verification testing. This paper suggests a partial combination of functional product and dummy product to demonstrate the package is capable of protecting…
…from damage throughout the distribution cycle. The most common mistake when undertaking this testing is that often, manufacturers stop short of combining the conditions of the entire supply chain on…
…from damage throughout the distribution cycle. The most common mistake when undertaking this testing is that often, manufacturers stop short of combining the conditions of the entire supply chain on…
…of Symbols in Labeling 510(k) Modifications Software Modifications 510(k) Third Party Review Program Companion Diagnostics Co-Development Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices UDI…
…of Symbols in Labeling 510(k) Modifications Software Modifications 510(k) Third Party Review Program Companion Diagnostics Co-Development Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices UDI…
…monitoring companies and early-stage companies that are developing clinical-grade wearables Healthcare spending will continue to dominate healthcare market (United States, Europe and Japan will hold on to 72% of market…
…monitoring companies and early-stage companies that are developing clinical-grade wearables Healthcare spending will continue to dominate healthcare market (United States, Europe and Japan will hold on to 72% of market…
…after the company received reports that switching the tubes from an older version to a newer version could lead to breathing problems. This issue could be due to the fact…
…after the company received reports that switching the tubes from an older version to a newer version could lead to breathing problems. This issue could be due to the fact…
…thing as maximum compliance or minimum compliance, there is only compliance.” It is Dr. D’s favorite quote. Enjoy! Warning Letter – December 11, 2015 For this last guidance of 2015,…
…thing as maximum compliance or minimum compliance, there is only compliance.” It is Dr. D’s favorite quote. Enjoy! Warning Letter – December 11, 2015 For this last guidance of 2015,…
…At EM-TRAC, Medtronic brings in physicians to participate in simulation training. 3: Medtronic’s European Research Center Focuses on Innovation for Survival The company’s Bakken Research Centre in the Netherlands is…
…At EM-TRAC, Medtronic brings in physicians to participate in simulation training. 3: Medtronic’s European Research Center Focuses on Innovation for Survival The company’s Bakken Research Centre in the Netherlands is…
With Christmas rapidly approaching, Dr. D hopes all of the readers that celebrate Christmas have completed their shopping. FYI, Dr. D has not but will begin shopping with a vengeance…
With Christmas rapidly approaching, Dr. D hopes all of the readers that celebrate Christmas have completed their shopping. FYI, Dr. D has not but will begin shopping with a vengeance…
