MEDICAL DEVICES

Device Experts

Our medical device experts are conversant with emerging trends in medical devices. We draw our pool of experts from the industry covering wide aspects of medical device usage: manufacturing, pre-clinical, clinical and the end users. Our Medical Device experts have years of experience in all aspects of medical devices. They are trained on MDR 2017/745, MDD 93/42/EEC, AIMDD 90/385/EEC, ISO 13485:2016, ISO 14155:2011, and ISO 14971:2007. Our experts are thought leaders who lead and generate vibrant discussion around the medical device compliance story.

Impartial

We understand the importance of being impartial for a notified body. To codify our commitment for serving the notified bodies, we have created a ring-fenced legal entity with an exclusive focus on the notified bodies. Our unit serving the notified bodies will operate as a separate legal entity devoid of any clash of commitment.

QMS

As a quality driven organization, our multiyear experience of implementing large, complex and multi layered QMS for medical device companies holds us in good stead to help implement the QMS across the organization.

Contact us to know more.

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