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MakroCare Blog

Deadline Extended for DMF Type III eCTD Submissions by FDA

Calendar August 29, 2019 Folder eCTD

This being the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for the submission of Type III Drug Master Files (DMFs) in electronic Common Technical Document (eCTD) format. With the deadline extended till May 5, 2020.

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Regulatory CMC Changes for Pharmaceutical Products

Calendar August 07, 2019 Folder CMC

All the biopharmaceutical companies must follow respective nation’s laws or regulations in order to develop, manufacture and sale their pharmaceutical products. Before any biopharmaceutical product goes in to market, it has to get marketing authorization from the relevant health authorities.

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Post Market Surveillance Planning and Challenges under EU MDR

Calendar July 11, 2019 Folder EU MDR

PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes.

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EUDAMED and EU Medical Device Nomenclature

Calendar March 20, 2019 Folder EU MDR

The European Commission explain the details of how a future system for medical device nomenclature will help to support the EU’s new device and IVD regulations, as well as the Eudamed database, which allows for information to be exchanged between national competent authorities and the Commission.

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Use of Retrospective RWD for EU MDR Compliance

Calendar March 12, 2019 Folder EU MDR

As EU MDR has already entered into force and will be applicable in May 2020, the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence and post marketing obligations on device companies in proportion with risk class and the type of device.

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Med Device PMCF: How to get right Sample size

Calendar March 05, 2019 Folder PMCF

Post Marketing Clinical Follow (PMCF) is a continuous process to assess and analyze clinical data pertaining to device to verify the clinical safety and performance of the device when used as intended by the manufacturer. Usually device studies are used to acknowledge the information to a manufacturer mainly on the below points:

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Labeling findings from FDA and other Agencies audits summary

Calendar March 01, 2019 Folder Labeling

Regulatory environment has become increasingly complex and making drug labeling a highly regulated and closely monitored activity. As some of you are aware, Health authorities are specific to regulatory requirements for medicinal products on labeling requirements such as patient information leaflets,

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Effect of GDPR on Medical Devices in EU

Calendar February 25, 2019 Folder EU MDR

Growth of technology brought forth internet enabled Medical Devices which can help with everything from the monitoring of patients to the collection and use of statistical data. This helps to improve medical care across the globe and progresses the medical knowledge of health professionals. The use of these devices provides many financial

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