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PMS Planning and Challenges under EU MDR

October 15, 2020 EU MDR

While Post Market Surveillance (PMS) is mentioned in Annex X of the existing Medical Device Directive (MDD), it was not defined clearly in the MDD. Lack of clarity.

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UDI : FDA versus EU with CND taking center stage than GMDN

September 24, 2020 EU MDR

With increasing concerns for patient safety and efficient supply chain management, a single, globally harmonized identification system for medical devices is needed.

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ISO 14971:2019 – Updates & older Version Differences

May 27, 2020 EU MDR

The third edition of ISO 14971 was finally released in December 2019 and it replaces ISO 14971:2007. The risk management process itself remains largely unchanged.

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EU MDR Implementation Extension - Helps in Compliance Planning

May 07, 2020 EU MDR

We all aware that the implementation date of Medical Device Regulations (EU) 2017/745 (EU MDR) been extended by one year (26 May 2021) and the amendment was published...

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FDA/EU/MHRA/TGA suggestions for ongoing clinical studies

April 08, 2020 EU MDR

There are several suggestions, recommendations from different health authorities for manufacturers to handle clinical trial aspects during this very challenging time of COVID.

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

April 06, 2020 EU MDR

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 EU MDR

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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RAPS - 2019 Regulatory Convergence Round-up by MakroCare

October 03, 2019 EU MDR

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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Post Market Surveillance Planning and Challenges under EU MDR

July 11, 2019 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...

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EUDAMED and EU Medical Device Nomenclature

March 20, 2019 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...

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Use of Retrospective RWD for EU MDR Compliance

March 12, 2019 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...

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Effect of GDPR on Medical Devices in EU

February 25, 2019 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...

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