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MakroCare Blog

Blog

Real-World Approach in Collecting Clinical Data for MDR & IVDR

April 06, 2020 Author

The deadline for MDR is drawing near and for IVDR too there is not much time. In such a situation, manufacturers are busy in the process of collecting all sorts of data.

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SSCP for Devices: Challenges and Approach

November 25, 2019 Author

As per EU MDR, for class III and implantable devices (other than custom-made or investigational devices), a manufacturer needs to provide a summary of safety and clinical performance (SSCP).

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6 Best Practices to Navigate and Sustain Regulatory Labeling Compliance

November 18, 2019 Author

It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling, the criticality doubles as it becomes necessary to not only be compliant but to even...

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RAPS - 2019 Regulatory Convergence Round-up by MakroCare

October 03, 2019 Author

Recently concluded RAPS- 2019 regulatory convergence at Philadelphia, PA was attended by a good number of representatives from pharma, biotech and device industries, from vendors offering...

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Deadline Extended for DMF Type III eCTD Submissions by FDA

August 29, 2019 Author

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...

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Regulatory CMC Changes for Pharmaceutical Products

August 07, 2019 Author

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...

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Post Market Surveillance Planning and Challenges under EU MDR

July 11, 2019 Author

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...

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EUDAMED and EU Medical Device Nomenclature

March 20, 2019 Author

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...

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Use of Retrospective RWD for EU MDR Compliance

March 12, 2019 Author

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...

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Med Device PMCF: How to get right Sample size

March 05, 2019 Author

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...

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Labeling findings from FDA and other Agencies audits summary

March 01, 2019 Author

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...

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Effect of GDPR on Medical Devices in EU

February 25, 2019 Author

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...

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