…your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008). The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to…
…your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008). The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to…
…abscesses, after undergoing an endoscopic procedure with your firm’s devices. Your firm submitted one MDR (MDR #8010047-2015-00218) to account for all the patients involved in the event. Your firm failed…
…abscesses, after undergoing an endoscopic procedure with your firm’s devices. Your firm submitted one MDR (MDR #8010047-2015-00218) to account for all the patients involved in the event. Your firm failed…
…organization’s MDR procedure. Please note, as of last week (August 14, 2015) the use of eMDR reporting formally went into effect. Dr. D strongly suggests becoming familiar with the FDA’s…
…organization’s MDR procedure. Please note, as of last week (August 14, 2015) the use of eMDR reporting formally went into effect. Dr. D strongly suggests becoming familiar with the FDA’s…
…include, but are not limited to, the following: Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.” Quality, Purity, Strength “The inspection revealed that…
…include, but are not limited to, the following: Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.” Quality, Purity, Strength “The inspection revealed that…
…Administration, Department of Health and Human Services, Subchapter H – Medical Devices. European Medical Device Regulations (MDR). Revisions of Medical Device Directives. Accessed May 12, 2015. Retrieved from: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm. Federal…
…Administration, Department of Health and Human Services, Subchapter H – Medical Devices. European Medical Device Regulations (MDR). Revisions of Medical Device Directives. Accessed May 12, 2015. Retrieved from: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm. Federal…
As much of the focus surrounding medical device regulation involves FDA and EU requirements, the regulations in Canada can be misunderstood. Although the degree of difficulty in regulatory approval varies…
As much of the focus surrounding medical device regulation involves FDA and EU requirements, the regulations in Canada can be misunderstood. Although the degree of difficulty in regulatory approval varies…
…complaint management, recalls, MDR, etc.). Dr. D always recommends to my clients to just bite the bullet and implement a Quality Management System that is in compliance with 21 CFR,…
…complaint management, recalls, MDR, etc.). Dr. D always recommends to my clients to just bite the bullet and implement a Quality Management System that is in compliance with 21 CFR,…
…fix the problem. Simply stated by FDA, if the determination is that an event is reportable as an MDR, then the device establishment better make darn sure a complaint investigation…
…fix the problem. Simply stated by FDA, if the determination is that an event is reportable as an MDR, then the device establishment better make darn sure a complaint investigation…
…manufactured, imported or used properly. FDA is working hard to ensure the safety of consumers. In fact, the Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for…
…manufactured, imported or used properly. FDA is working hard to ensure the safety of consumers. In fact, the Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for…
…organization ascertain if a service call may actually be a complaint that must be reported as an MDR (in accordance with Part 803) if information relating to service calls is…
…organization ascertain if a service call may actually be a complaint that must be reported as an MDR (in accordance with Part 803) if information relating to service calls is…
