Davidbhagya

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Clinical Evaluation of Medical Devices

Davidbhagya23 Nov, 2020Health

Unlike previous versions, CER Rev 4 has some of the requirements that are very different and just updating based on literature strategy alone will increase your risk of rejection. As Rev 4 needs �Equivalence / Predicate� to be seen from a different perspective, right team of medical, regulatory, technical and scientific disciplines is key to ensure higher quality of CER that�s not only satisfies NBs but also conveys right information to healthcare community.

PMS planning and Challenges under EUMDR

Davidbhagya20 Nov, 2020Health

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 is completely removed with the publication of the new EU MDR. Not only is PMS defined in Article 2 (60), it is listed as one of the general obligations of all manufacturers (new Article 10). It is also one of the topics specifically called out for monitoring by the person responsible for regulatory compliance (new Article 15).

EU Medical Device Regulation Implementation services

Davidbhagya23 Oct, 2020Health

The European Union�s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU.

IVDR Consulting services | Makrocare

Davidbhagya22 Oct, 2020Health

What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).Our IVD team has a broad range of industry and regulatory experience, and is able to offer CE certification services for IVD medical devices under the IVDR. Examples of products we cover include:

IVDR Compliance & Regulatory Consulting Services

Davidbhagya22 Oct, 2020Health

Medical Device Labeling Consulting Firm|Medical Device Labeling Consulting Services

Davidbhagya15 Oct, 2020Health

Medical device 'labeling' as the term is , as defined by the Food Drug and Cosmetic Act (FDCA), exceeds just the printed label on the device and will encompass all device's accompanying brochures, manuals, marketing materials and websites. Claims that surpass the clearance, the approval, or the applicable FDA regulation will cause the medical device to leap into an unapproved medical device category and therefore subject to FDA enforcement's.