…evidence of compliance? Seriously, the FDA expects: (a) a containment statement, (b) a realistic plan to achieve compliance, (c) actual documented evidence to support compliance has been achieved, and (d)…
…evidence of compliance? Seriously, the FDA expects: (a) a containment statement, (b) a realistic plan to achieve compliance, (c) actual documented evidence to support compliance has been achieved, and (d)…
…an example of our commitment to further investing in jobs and innovation as a result of the recent suspension of the medical device tax.” Last year Mayo Clinic treated about…
…an example of our commitment to further investing in jobs and innovation as a result of the recent suspension of the medical device tax.” Last year Mayo Clinic treated about…
…foster a competitive environment for skilled foreign workers and companies. Offering advantages such as a 12.5% tax on corporate trading activities has helped Ireland attract medtech companies in traditional as…
…foster a competitive environment for skilled foreign workers and companies. Offering advantages such as a 12.5% tax on corporate trading activities has helped Ireland attract medtech companies in traditional as…
…provides more flexibility versus purchasing off-the-shelf products, but with it comes a greater risk of vulnerability, said Morgan. Software moves quickly, and open source packages are maintained faster, so companies…
…provides more flexibility versus purchasing off-the-shelf products, but with it comes a greater risk of vulnerability, said Morgan. Software moves quickly, and open source packages are maintained faster, so companies…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Repro-Med Systems, Inc….
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Repro-Med Systems, Inc….
…and decision-support systems. Another prominent field is bio-hybrid systems where technical and biological components are combined as hybrid implant solutions for cardiovascular deficiencies or cartilage defects. MTI: What incentives does…
…and decision-support systems. Another prominent field is bio-hybrid systems where technical and biological components are combined as hybrid implant solutions for cardiovascular deficiencies or cartilage defects. MTI: What incentives does…
My firm has been working in the Chinese medical device market for more than 25 years. We help foreign device companies register, source and sell devices there. About 10 years…
My firm has been working in the Chinese medical device market for more than 25 years. We help foreign device companies register, source and sell devices there. About 10 years…
…of the medical device. In fact, there is also a statement that unique identification, when required, shall be incorporated. In order to comply with ISO 13485:2016, the company must now…
…of the medical device. In fact, there is also a statement that unique identification, when required, shall be incorporated. In order to comply with ISO 13485:2016, the company must now…
A look at some common mistakes medical device companies make when approaching risk….
A look at some common mistakes medical device companies make when approaching risk….
…2016. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM488020.pdf FDA. (February 2016). Regulatory History. Accessed February 2, 2016. Retrieved from http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452270.htm FDA. (February 2016). Essure Permanent Birth Control. Accessed February 2, 2016. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/default.htm…
…2016. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM488020.pdf FDA. (February 2016). Regulatory History. Accessed February 2, 2016. Retrieved from http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452270.htm FDA. (February 2016). Essure Permanent Birth Control. Accessed February 2, 2016. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/default.htm…
