Our Post approval and Late Phase services offer innovative, Technology-Driven Centralized solution to design and execute these studies more cost effectively
MakroCare is a leading biotech, pharma and medical device consulting for Clinical Development, Regulatory affairs, Regulatory Operation, Publishing, Labeling, Med Affairs, Central Monitoring and RBM services.for more info visit:https://www.makrocare.com/blog/devices-and-diagnostics-439-clinical-studies-for-covid-19
Since decades, regulation of the medical device industry in Europe has been rather unchanged.
However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry.
The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.for more info visit:https://www.makrocare.com/devices/medical-device-regulationhttps://www.makrocare.com/devices/medical-device-regulation
If you are single product Device Company or single country multi-product company or a company with mostly low risk devices, externalizing with a partner on labeling work may not add high value to your bottom-line.for more info visit:https://www.makrocare.com/blog/device-label-externalizing-or-outsourcing
Global regulatory differences and constant changes to HA submission requirements even in the age of the Common Technical Document and the eCTD.for more info visit:https://www.makrocare.com/biopharma/regulatory/authoring/cmc
We support worldwide clients in the evaluation of clinical data documented as Clinical Evaluation Reports along with related documents which are part of the technical documentation, followed by assisting with submission to the notified body as part of the official conformity process for your medical device(s).for more info visit:https://www.makrocare.com/devices/clinical/clinical-evaluation-reports
IVD manufacturers need to navigate their way through a complex landscape of regulatory requirements before selling their products on the international and European markets.
They need to make sure their products comply with the respective standards and regulations.our in-vitro-diagnostic medical devices certification team have extensive expertise in a wide array of in-vitro-diagnostic devices.https://www.makrocare.com/devices/ivdr
If you are single product Device Company or single country multi-product company or a company with mostly low risk devices, externalizing with a partner on labeling work may not add high value to your bottom-line.for more info visit:https://www.makrocare.com/blog/device-label-externalizing-or-outsourcing
Since decades, regulation of the medical device industry in Europe has been rather unchanged.
However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry.
The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.for more info visit: https://www.makrocare.com/devhttps://www.makrocare.com/devices/medical-device-regulationices/medical-device-regulation
Our Post approval and Late Phase services offer innovative, Technology-Driven Centralized solution to design and execute these studies more cost effectively
We support worldwide clients in the evaluation of clinical data documented as Clinical Evaluation Reports along with related documents which are part of the technical documentation, followed by assisting with submission to the notified body as part of the official conformity process for your medical device(s).for more info visit:https://www.makrocare.com/devices/clinical/clinical-evaluation-reports
MakroCare is a leading biotech, pharma and medical device consulting for Clinical Development, Regulatory affairs, Regulatory Operation, Publishing, Labeling, Med Affairs, Central Monitoring and RBM services.for more info visit:https://www.makrocare.com/blog/devices-and-diagnostics-439-clinical-studies-for-covid-19
IVD manufacturers need to navigate their way through a complex landscape of regulatory requirements before selling their products on the international and European markets.
They need to make sure their products comply with the respective standards and regulations.our in-vitro-diagnostic medical devices certification team have extensive expertise in a wide array of in-vitro-diagnostic devices.https://www.makrocare.com/devices/ivdr
Since decades, regulation of the medical device industry in Europe has been rather unchanged.
However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry.
The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.for more info visit:https://www.makrocare.com/devices/medical-device-regulationhttps://www.makrocare.com/devices/medical-device-regulation
If you are single product Device Company or single country multi-product company or a company with mostly low risk devices, externalizing with a partner on labeling work may not add high value to your bottom-line.for more info visit:https://www.makrocare.com/blog/device-label-externalizing-or-outsourcing
If you are single product Device Company or single country multi-product company or a company with mostly low risk devices, externalizing with a partner on labeling work may not add high value to your bottom-line.for more info visit:https://www.makrocare.com/blog/device-label-externalizing-or-outsourcing
Global regulatory differences and constant changes to HA submission requirements even in the age of the Common Technical Document and the eCTD.for more info visit:https://www.makrocare.com/biopharma/regulatory/authoring/cmc
Since decades, regulation of the medical device industry in Europe has been rather unchanged.
However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry.
The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.for more info visit: https://www.makrocare.com/devhttps://www.makrocare.com/devices/medical-device-regulationices/medical-device-regulation