Barbara SauleBalancing Agile and Regulatory Compliance: managing CE-marked software as a Medical DeviceIn the realm of medical device software, integrating agile methodology with CE marking requirements presents unique challenges. Agile…Sep 19
Matt SharonFDA Medical Device Registration Process GuideThe FDA Medical Device Registration Process is a requirement for all medical devices that are manufactured or imported into the United…May 29, 2023
InI3CGLOBAL BlogsbySEO AgencyBest Medical Equipment ConsultantsHigh-quality medical equipment is a key determinant in the delivery of quality health care services in the healthcare industry.Sep 18Sep 18
Dana CraneSBOMs for Medical Devices — Everything You Need to KnowThe US Food and Drug Administration (FDA) has mandated SBOMs for medical devices running any kind of software must create and maintain a…Aug 25, 20231Aug 25, 20231
InI3CGLOBAL BlogsbySEO AgencyClinical Evaluation Consultants for Medical Devices and IVDsClinical evaluation is a critical component of the regulatory approval process for medical devices and in vitro diagnostics (IVDs). It…Jun 22Jun 22
Barbara SauleBalancing Agile and Regulatory Compliance: managing CE-marked software as a Medical DeviceIn the realm of medical device software, integrating agile methodology with CE marking requirements presents unique challenges. Agile…Sep 19
Matt SharonFDA Medical Device Registration Process GuideThe FDA Medical Device Registration Process is a requirement for all medical devices that are manufactured or imported into the United…May 29, 2023
InI3CGLOBAL BlogsbySEO AgencyBest Medical Equipment ConsultantsHigh-quality medical equipment is a key determinant in the delivery of quality health care services in the healthcare industry.Sep 18
Dana CraneSBOMs for Medical Devices — Everything You Need to KnowThe US Food and Drug Administration (FDA) has mandated SBOMs for medical devices running any kind of software must create and maintain a…Aug 25, 20231
InI3CGLOBAL BlogsbySEO AgencyClinical Evaluation Consultants for Medical Devices and IVDsClinical evaluation is a critical component of the regulatory approval process for medical devices and in vitro diagnostics (IVDs). It…Jun 22
Interlynksbomasm: SBOM Assembly for Software ProductsBuilding the Software Bill of Materials, or “SBOM” — alongside the software itself — is a good practice for monitoring zero-day…Jul 16, 2023
InI3CGLOBAL BlogsbySEO AgencyMedical Device Technical File Consultants: Ensuring Compliance and Market SuccessNavigating the complex regulatory landscape of medical device approval requires meticulous attention to detail, especially when it comes to…Jun 19
InJavarevisitedbyManishaKey Reasons to Integrate Medical Device SoftwareHealthcare technology has seen remarkable advancements over the years, and medical devices have become essential tools for diagnosing…Sep 131
